Annuloplasty systems and locking tools therefor

ABSTRACT

Apparatuses and systems are provided including a contracting member fastener. The contracting member fastener can surround the contracting member and include a clamping structure that is biased toward assuming a closed state to clamp onto the contracting member passed therethrough. A stop can be removably coupled to the fastener and maintain the fastener in an open state. A contracting-member-uptake tool can include static and dynamic cutting elements and graspers configured to pull stop proximally such that the stop pushes against and moves the dynamic cutting element with respect to the static cutting element in order to facilitate severing of the contracting member. Other applications are also provided.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a continuation of PCT Application No.PCT/IL2019/050777 filed on Jul. 11, 2019, which claims priority from:

a) U.S. Provisional Patent Application 62/697,186 to Brauon et al.,entitled: “Annuloplasty system and locking tool therefor,” filed on Jul.12, 2018; and

b) U.S. Provisional Patent Application 62/811,693 to Brauon et al.,entitled: “Annuloplasty system and locking tool therefor,” filed on Feb.28, 2019.

All of these applications are incorporated herein by reference in theirentirety.

FIELD OF THE INVENTION

The present invention relates in general to valve repair, for example,to repair of an atrioventricular valve of a patient.

BACKGROUND

Ischemic heart disease can cause valvular regurgitation. For example,mitral regurgitation can be caused by the combination of ischemicdysfunction of the papillary muscles, and the dilatation of the leftventricle that is present in ischemic heart disease, with the subsequentdisplacement of the papillary muscles and the dilatation of the mitralvalve annulus.

Dilation of the annulus of the mitral valve can prevent the valveleaflets from fully coapting when the valve is closed. Mitralregurgitation of blood from the left ventricle into the left atriumresults in increased total stroke volume and decreased cardiac output,and ultimate weakening of the left ventricle secondary to a volumeoverload and a pressure overload of the left atrium.

SUMMARY

This summary is meant to provide some examples and is not intended to belimiting of the scope of the invention in any way. For example, anyfeature included in an example of this summary is not required by theclaims, unless the claims explicitly recite the features. Also, thefeatures, components, steps, concepts, etc. described in examples inthis summary and elsewhere in this disclosure can be combined in avariety of ways. The description herein relates to systems, assemblies,methods, devices, apparatuses, combinations, etc. that may be utilizedfor valve repair. Various features and steps as described elsewhere inthis disclosure can be included in the examples summarized here.

In some applications, a multi-component tubular system is provided foraccessing a heart of a patient. The system can comprise one or moresteerable guiding catheters (e.g., 1, 2, 3, or more) configured fordirecting the passage of devices therethrough into the heart. Themulti-component tubular system can be configured to deliver an implantin a desired orientation to an annulus of a cardiac valve of the patientand to facilitate anchoring of the implant to the annulus. For someapplications, the guiding system can be advanced/advanceabletransluminally or transthoracically accessing an atrium of the heart.For some applications, the guiding system can be advanced surgically.The system can comprise two or more steerable catheters. A firstcatheter has a distal portion that is steerable to a first desiredspatial orientation. A second catheter is disposed within the firstcatheter and has a distal portion that is steerable to a second desiredspatial orientation. The system provides techniques andrelative-spatial-orientation-controlling devices for controlling theorientation of the distal portion of the second catheter with respect tothe first catheter without substantially distorting the first spatialorientation of the distal portion of the first catheter. For someapplications, the relative-spatial-orientation-controlling devicecomprises a rotational locking mechanism provided by components of thecatheter system.

The distal portion of the first catheter can be steered in a suitabledirection following advancement of the first catheter throughvasculature of the patient. Following the advancement of the firstcatheter and steering of the distal portion of the first catheter in anyone or more suitable planes, the second catheter is advanced through thefirst catheter. The first and second catheters can be rotationallylocked in order to enable steering of the distal portion of the secondcatheter in any one or more suitable planes with respect to the distalportion of the first catheter in a manner which substantially maintainsthe spatial orientation of the first catheter during the steering of thesecond catheter. Additionally, the first catheter can be further steeredwithout substantially disrupting the spatial orientation of the distalportion of the second catheter.

The distal portions and/or distal ends of the first and second catheterscan be configured such that once they have been positioned within anatrium of the heart of the patient, an implantable, adjustableannuloplasty structure (e.g., an annuloplasty ring structure, a closedannuloplasty structure, a closed annuloplasty ring structure, an openannuloplasty structure, a partial annuloplasty ring structure, or otherannuloplasty device) can be deployed, e.g., from within the secondcatheter and anchored to the annulus of the cardiac valve of thepatient. The annuloplasty structure can comprise a flexible primary bodyportion and a contracting member having a first portion extending alonga longitudinal length of the primary body portion. A second portion ofthe contracting member can extend away from the primary body portion ofthe annuloplasty structure and outside the body of the patient. From alocation outside the body of the patient, contracting-member-snare of acontracting-member-uptake tool is used to ensnare a proximal end portionof the contracting member that is disposed outside of the body of thepatient. Using the snare, the proximal end portion of the contractingmember can then be fed through a distal portion of a primary tube of thetool and subsequently through a lumen of a secondary tube of the tool.The contracting-member-uptake-tool can then be advanced toward theannulus of the patient along the contracting member. During theadvancing of the tool toward the annulus, the secondary tube of the toolcan move distally along the contracting member as the contracting memberpasses through the lumen of the secondary tube of the tool by beingpulled by the snare.

The contracting-member-uptake-tool can comprise an ejector movable adistal end portion of the tool. The ejector can be removably coupled toa suture fastener which comprises a clamping structure that can beflexed to an open condition through which the contracting member canpass and is biased toward a closed position or closed state which clampsonto the contracting member passed therethrough. The tool can have atleast one stop that maintains the suture fastener (e.g., the clampingstructure thereof) in its open condition.

The snare portion can be configured or adapted to capture and pull thecontracting member proximally through the suture fastener and out of thealigned ports in the tool. The tool can then be advanced toward theannuloplasty structure implanted along the annulus. The tool can thenuptake successive portions of the contracting member in order tocontract the annuloplasty structure. Subsequently, the ejector of thetool can be moved and converts the suture fastener (e.g., the clampingstructure thereof) from its open condition to its closed condition toclamp onto the contracting member passed therethrough.

The tool can comprise a handle portion which can comprise acontracting-member-uptake device which uptakes successive portions ofthe contracting member. The handle portion can comprise a tension meterconfigured to measure a degree of tension of the contracting member.

For some applications, an annuloplasty structure (e.g., an annuloplastyring structure, a closed annuloplasty structure, a closed annuloplastyring structure, an open annuloplasty structure, a partial annuloplastyring structure, or other annuloplasty device) comprises a primary bodyportion comprising a contractible sleeve, a contracting member threadedalong the contractible sleeve, and a housing comprising a fastenerthrough which the contracting member passes. Once the annuloplastystructure or annuloplasty ring structure has been contracted, thefastener is deployed within the housing in order to maintain contractionof the annuloplasty structure or annuloplasty ring structure.

A contracting-member-severing tool is provided in which severing of thecontracting member running through the tool is possible only once thecontracting member has been locked in place by a fastener coupledthereto. The contracting-member-severing tool can be configured in avariety of ways to apply a cutting surface to the contracting member,e.g., with a sharp edge that moves toward the contracting member;multiple edges and/or surfaces that move relative to each other such asin a scissoring motion or like a wire cutter tool; etc.

There is therefore provided, in accordance with some applications, asystem and/or an apparatus, including an implantable annuloplastystructure. The annuloplasty structure including a primary body portionand a contracting member. In some implementations, the contractingmember can have (1) a first portion extending along a longitudinallength of the primary body portion of the annuloplasty structure, and(2) a second portion extending away from the primary portion of theannuloplasty structure.

The system and/or apparatus can include a contracting-member-uptaketool. The contracting-member-uptake tool can include a primary tubeterminating at a distal end portion of the contracting-member-uptaketool, the distal end portion of the contracting-member-uptake toolhaving a distal tip, and a secondary tube disposed alongside the primarytube, the secondary tube having a secondary-tube lumen being configuredfor passage therethrough of the contracting member. In someimplementations, the contracting-member-uptake tool also includes acontracting-member snare including a distal snare portion and anelongate flexible body portion coupled to the distal snare portion, thedistal snare portion being configured to ensnare a portion of thecontracting member. The contracting-member snare can be sized to passthrough the secondary-tube lumen of the secondary tube in order to pullthe second portion of the contracting member through a length of thesecondary tube.

For some applications, the distal snare portion is configured to pullthe second portion of the contracting member through the distal tip ofthe contracting-member-uptake tool and subsequently through the lengthof the secondary tube.

For some applications, the contracting-member-snare includes a wireincluding stainless steel. For some applications, thecontracting-member-snare includes a wire having a diameter of 0.2-0.25mm.

For some applications, the primary tube and/or the secondary tube isflexible.

For some applications, the annuloplasty structure defines a fullannuloplasty ring structure. For some applications, the annuloplastystructure defines a partial annuloplasty ring structure.

For some applications, the secondary tube is shaped to define alongitudinal slit.

For some applications, the contracting-member-uptake tool includes ahandle portion and the first and second tubes are connected to thehandle portion.

For some applications, the handle portion includes acontracting-member-uptake device configured to uptake successiveportions of the contracting member; and a tension meter configured tomeasure a degree of tension of the contracting member.

For some applications, the contracting-member-uptake device isactuatable to increase tension of the contracting member.

For some applications, the contracting-member-uptake device includes aknob coupled to a proximal portion of the contracting member, the knobbeing configured to increase tension of the contracting member bypulling the contracting member proximally. For some applications, theknob is fixedly coupled to the proximal portion of the contractingmember.

For some applications, the contracting-member-uptake device includes awheel having a groove configured to couple the contracting member to thewheel. For some applications, the groove is shaped so as to receive amiddle portion of the contracting member.

For some applications, the secondary-tube lumen of the secondary tube issized so as to maintain coupling between the distal snare portion andthe contracting member.

For some applications, the snare portion includes a flexible loop, andthe secondary-tube-lumen is configured to collapse the loop around thecontracting member as the elongate flexible body portion is pulledthrough the secondary-tube-lumen. For some applications, thesecondary-tube lumen of the secondary tube has a diameter of 0.5-1.5 mm.

For some applications, the contracting-member-snare includes a metalwire.

For some applications, at least the distal snare portion of thecontracting-member-snare is corrugated to increase friction between thesnare portion and the contracting member.

For some applications, the distal snare portion is configured pull thesecond portion of the contracting member through an entire length of thesecondary tube.

For some applications, the contracting member-uptake tool includes: atleast one contracting-member-fastener disposed within the distal endportion of the contracting-member-uptake tool, thecontracting-member-fastener including a clamping structure that (a) isbiased toward assuming a closed state, in the closed state, the clampingstructure is configured to clamp onto the contracting member passedtherethrough, and (b) can be flexed to an open state through which thecontracting member can move; and a stop removably coupled to thecontracting-member-fastener and configured to maintain thecontracting-member-fastener in the open state.

For some applications, the at least one contracting-member-fastenerincludes at least first and second contracting-member-fastener disposedwithin the distal end portion of the contracting-member-uptake tool.

For some applications, the distal snare portion and the elongateflexible body portion of the contracting-member-snare are sized to passdistally through the contracting-member-fastener in the open state, thesnare portion being adapted to capture and pull the contracting memberproximally through the contracting-member-fastener and through alignedports in the distal end portion of the contracting-member-uptake tool.

For some applications, the contracting-member-uptake tool includes afastener-ejector movable within the distal end portion of thecontracting-member-uptake tool, and movement of the fastener-ejectorcontacts and converts the contracting-member-fastener from the openstate to the closed state to clamp onto the contracting member passedtherethrough.

For some applications, the fastener-ejector is coupled to the stop andmoves the stop that is removably coupled to the fastener.

For some applications, the distal end portion of thecontracting-member-uptake tool is shaped so as to define a sharp edge,and the contracting member is disposed in proximity to the sharp edgesuch that movement of the fastener-ejector against the sharp edge seversthe contracting member extending through the fastener.

For some applications, the system and/or apparatus further includes: atleast one contracting-member-fastener configured to surround thecontracting member, the contracting-member-fastener including a clampingstructure that (a) is biased toward assuming a closed state, in theclosed state, the clamping structure is configured to clamp onto thecontracting member passed therethrough, and (b) can be flexed to an openstate through which the contracting member can move; and a stopremovably coupled to the contracting-member-fastener and configured tomaintain the contracting-member-fastener in the open state.

For some applications, the contracting-member-uptake tool includes afastener-ejector movable within the distal end portion of thecontracting-member-uptake tool, and movement of the fastener-ejector isconfigured to convert the contracting-member-fastener from the openstate to the closed state to clamp onto the contracting member passedtherethrough.

For some applications, the fastener-ejector is removably coupled to thestop and moves the stop that is removably coupled to the fastener.

For some applications, the tool includes a moveable cutting elementhaving a sharp edge, and movement of the stop hammers the stop againstthe moveable cutting element such that movement of the moveable cuttingelement severs the contracting member extending through the fastener andthrough the moveable cutting element.

For some applications, the system and/or apparatus further includes alock slidable along the contracting member, the lock being fixedlycouplable to the contracting member in order to prevent movement of thecontracting member. The lock can be shaped so as to define a slit whichextends from a proximal surface of the lock toward a distal surface ofthe lock. The lock can define a lock lumen of the lock extending from aproximal opening in the lock toward a distal opening in the lock. Thelock lumen can be configured to surround the contracting member. In someapplications, when the lock is compressed, the slit enables the lock toclose around the contracting member and thereby lock the lock to thecontracting member.

For some applications, the annuloplasty structure is shaped so as todefine a recess dimensioned so as to compress the lock when the lock isdisposed at least in part within the recess.

For some applications, the recess is dimensioned so as to compress thelock when the lock is disposed at least in part within the recess.

For some applications, the lock lumen is shaped so as to define a distalportion that is wider than a proximal portion of the lock lumen.

For some applications, the recess is shaped so as to define a proximalportion that is narrower than any other portion of the recess distal tothe proximal portion.

For some applications, the lock is disposed within the distal endportion of the contracting-member-uptake tool.

For some applications, when the contracting-member-uptake tool iscoupled to the annuloplasty structure, the lock is disposed at least inpart within the recess.

For some applications, when the contracting-member-uptake tool iscoupled to the annuloplasty structure, the lock is disposed entirelyproximally to the recess.

For some applications, the lock is disposed within the distal endportion of the contracting-member-uptake tool.

For some applications, the distal snare portion and the elongateflexible body portion of the contracting-member-snare are sized to passdistally through lock, the snare portion adapted to capture and pull thecontracting member proximally through the lock and through aligned portsin the distal end portion of the contracting-member-uptake tool.

There is further provided, in accordance with some applications, asystem and/or an apparatus, including an implantable annuloplastystructure. The implantable annuloplasty structure including a primarybody portion and a contracting member. The contracting member can have(1) a first portion extending along a longitudinal length of the primarybody portion of the annuloplasty ring structure, and (2) a secondportion extending away from the primary body portion of the annuloplastyring structure.

The system and/or apparatus can also include a housing configured to bepositionable against the primary body portion of the annuloplasty ringstructure.

The system and/or apparatus can also include acontracting-member-fastener disposed at least in part within thehousing, the contracting-member-fastener including a clamping structurethat (a) is biased toward assuming a closed state, in the closed state,the clamping structure is configured to clamp onto the contractingmember passed therethrough, and (b) can be flexed to an open statethrough which the contracting member can move.

The system and/or apparatus can also include a stop removably coupled tothe fastener and configured to maintain the contracting-member-fastenerin the open state; and a fastener-ejector engageable with the stop suchthat movement of the fastener-ejector moves the stop removably coupledto the fastener and converts the clamping structure from the open stateto the closed state to clamp onto the contracting member passedtherethrough.

For some applications, the fastener-ejector is shaped such that movementthereof facilitates severing of the contracting member extending throughthe fastener.

For some applications, the fastener includes a deformable element havinga slanted state and a straight state, the stop is configured to maintainthe fastener in the slanted state, and, upon removal of the stop, thefastener is configured to transition to the straight state and claim thecontracting member between the fastener and a surface of the housing.

For some applications, the fastener is shaped so as to define aplurality of teeth configured to increase friction between thecontracting member and the fastener.

There is further provided, in accordance with some applications, amethod, including advancing toward a heart of a patient an implantableannuloplasty structure including a primary body portion and acontracting member. The contracting member be the same as or similar toother contracting members herein and can have (1) a first portionextending along a longitudinal length of the primary body portion of theannuloplasty structure, and (2) a second portion extending away from theprimary portion of the annuloplasty ring structure.

The method further includes threading the second portion of thecontracting member through a contracting-member-uptake tool. Thecontracting-member-uptake tool can include a primary tube terminating ata distal end portion of the contracting-member-uptake tool, the distalend portion of the contracting-member-uptake tool having a distal tipand a secondary tube disposed alongside the primary tube, the secondarytube having a secondary-tube lumen being configured for passagetherethrough of the contracting member. The contracting-member-uptaketool can also include a contracting-member-snare including a distalsnare portion and an elongate flexible body portion coupled to thedistal snare portion, the distal snare portion being configured toensnare a portion of the contracting member and being sized to passthrough the secondary-tube lumen of the secondary tube in order to pullthe second portion of the contracting member through a length of thesecondary tube.

For some applications, the threading includes using the distal snareportion, ensnaring the portion of the contracting member; using thecontracting-member-snare, pulling the portion of the contracting memberthrough the secondary tube; and subsequently to the threading, advancingthe contracting-member-uptake tool along the contracting member towardthe annuloplasty structure.

For some applications, threading the second portion of the contractingmember includes threading the second portion of the contracting membersubsequently to the advancing.

For some applications, pulling the portion of the contracting memberthrough the secondary tube includes pulling the second portion of thecontracting member through the distal tip of thecontracting-member-uptake tool and subsequently through the length ofthe secondary tube.

For some applications, pulling the portion of the contracting memberthrough the secondary tube includes strengthening a coupling between thecontracting member and the snare portion.

For some applications, the method further includes, subsequently to theadvancing of the contracting-member-uptake tool, contracting theannuloplasty structure using the contracting-member-uptake tool.

For some applications, contracting the annuloplasty structure using thecontracting-member-uptake tool includes advancing successive portions ofthe contracting member with respect to a contracting-member-uptakedevice.

For some applications, the method further includes, subsequently to thecontracting, maintaining the annuloplasty structure in a contractedstate by clamping a contracting-member-fastener around a portion of thecontracting member.

For some applications, clamping includes deploying the fastener fromwithin the distal end portion of the contracting-member-uptake tool.

For some applications, the method further includes, subsequently to themaintaining the annuloplasty structure in the contracted state, using asharp edge of the contracting-member-uptake tool, severing thecontracting member.

For some applications, advancing the contracting-member-uptake toolincludes advancing the contracting-member-uptake tool throughvasculature of the patient.

For some applications, contracting-member-uptake tool includes a handleportion including a contracting-member-uptake device configured touptake successive portions of the contracting member; and a tensionmeter configured to measure a degree of tension of the contractingmember.

For some applications, the method further includes increasing tension ofthe contracting member using the contracting-member-uptake device.

For some applications, the contracting-member-uptake device includes awheel and having a groove, and the method further includes coupling thecontracting member to the wheel.

For some applications, coupling the contracting member to the wheelincludes coupling a middle portion of the contracting member to thewheel.

The method can be performed in a procedure on a living animal or in asimulation/simulated procedure (e.g., on a cadaver, cadaver heart,simulator with a simulated heart, tissue, etc., anthropomorphic ghost,etc.).

There is further provided, in accordance with some applications, amethod, including advancing toward a heart of a patient an implantableannuloplasty structure. The implantable annuloplasty structure can bethe same as or similar to other annuloplasty structures herein orotherwise known, and can include, for example, a primary body portion, acontracting member, and a housing coupled to the primary body portion ofthe annuloplasty structure. For some applications the contracting memberhas (1) a first portion extending along a longitudinal length of theprimary body portion of the annuloplasty structure, and (2) a secondportion extending away from the primary body portion of the annuloplastystructure.

For some applications, a contracting-member-fastener is disposed withinthe housing, the contracting-member-fastener including a clampingstructure that (a) is biased toward assuming a closed state, in theclosed state, the clamping structure is configured to clamp onto thecontracting member passed therethrough, and (b) can be flexed to an openstate through which the contracting member can move. For someapplications, a stop is removably coupled to the fastener and configuredto maintain the contracting-member-fastener in the open state.

For some applications, the method further includes converting thecontracting-member-fastener from the open state to the closed state inorder to clamp onto the contracting member passed therethrough by movinga fastener-ejector engageable with the stop such that movement of thefastener-ejector moves the stop removably coupled to the fastener.

For some applications, the method further includes, subsequently to theadvancing, contracting the annuloplasty structure using the contractingmember, and converting the contracting-member-fastener from the openstate to the closed state including converting subsequently to thecontracting.

For some applications, contracting the annuloplasty structure includescontracting the annuloplasty structure using a contracting-member-uptaketool.

For some applications, contracting the annuloplasty structure using thecontracting-member-uptake tool includes advancing successive portions ofthe contracting member with respect to a contracting-member-uptakedevice.

For some applications, the method further includes, subsequently to theconverting of the contracting-member-fastener from the open state to theclosed state, using a sharp edge of the contracting-member-uptake tool,severing the contracting member.

The method can be performed in a procedure on a living animal or in asimulation/simulated procedure (e.g., on a cadaver, cadaver heart,simulator with a simulated heart, tissue, etc., anthropomorphic ghost,etc.).

There is further provided, in accordance with some applications, asystem, including an implantable annuloplasty structure including aprimary body portion and a contracting member extending at leastpartially along a longitudinal length of the primary body portion of theannuloplasty structure. The system also includes acontracting-member-uptake tool. The contracting-member-uptake tool caninclude a tube having a lumen configured for passage therethrough of thecontracting member and a contracting-member-snare. Thecontracting-member snare can include a distal snare portion and anelongate flexible body portion coupled to the distal snare portion, thedistal snare portion being configured to ensnare a portion of thecontracting member and pull it into the lumen.

For some applications, the distal snare portion is configured to pullthe portion of the contracting member through an entire length of thelumen.

For some applications, the contracting-member-snare includes a wireincluding stainless steel. For some applications, the tube is flexible.

For some applications, the contracting-member-uptake tool includes ahandle portion and the tube is connected to the handle portion.

For some applications, the handle portion includes acontracting-member-uptake device configured to uptake successiveportions of the contracting member; and a tension meter configured tomeasure a degree of tension of the contracting member.

For some applications, the contracting-member-uptake device isactuatable to increase tension of the contracting member.

For some applications, the contracting-member-uptake device includes awheel having a groove configured to couple the contracting member to thewheel.

For some applications, the groove is shaped so as to receive a middleportion of the contracting member.

For some applications, the lumen of the tube is sized so as to maintaincoupling between the distal snare portion and the contracting member.

For some applications, the distal snare portion includes a flexibleloop, and the lumen is configured to collapse the loop around thecontracting member as the portion of the contracting member is pulledthrough the lumen.

For some applications, at least the distal snare portion of thecontracting-member-snare is corrugated to increase friction between thesnare portion and the contracting member.

For some applications, the distal end portion of thecontracting-member-uptake tool is shaped so as to define a sharp edge,and the contracting member-uptake tool is configured to dispose thecontracting member in proximity to the sharp edge such that the sharpedge can sever the contracting member.

For some applications, the contracting member-uptake tool includes:

a contracting-member-fastener disposed within the distal end portion ofthe contracting-member-uptake tool, the contracting-member-fastenerincluding a clamping structure that (a) is biased toward assuming aclosed state, in the closed state, the clamping structure is configuredto clamp onto the contracting member passed therethrough, and (b) can beflexed to an open state through which the contracting member can move;and

a stop removably coupled to the contracting-member-fastener andconfigured to maintain the contracting-member-fastener in the openstate.

For some applications, the distal snare portion and the portion of thecontracting-member are sized to pass distally through thecontracting-member-fastener in its open state, the distal snare portionbeing adapted to capture and pull the portion of the contracting memberproximally through the contracting-member-fastener and through alignedports in the distal end portion of the contracting-member-uptake tool.

For some applications, the contracting-member-uptake tool includes afastener-ejector movable within the distal end portion of thecontracting-member-uptake tool, and movement of the fastener-ejectorcontacts and can convert the contracting-member-fastener from its openstate to its closed state to clamp onto the contracting member whenpassed therethrough.

For some applications, the fastener-ejector is coupled to the stop andmoves the stop that is removably coupled to the fastener.

For some applications, the distal end portion of thecontracting-member-uptake tool is shaped so as to define a sharp edge,and the contracting-member-uptake tool is configured to dispose thecontracting member in proximity to the sharp edge such that movement ofthe fastener-ejector against the sharp edge severs the contractingmember after where it extends through the fastener.

For some applications, the implantable annuloplasty structure is aclosed annuloplasty structure.

There is further provided, in accordance with some applications, asystem and/or apparatus, including an implantable annuloplasty structureincluding a primary body portion having a lateral wall and a contractingmember. In some applications, the contracting member has (1) a firstportion extending along a longitudinal length of the primary bodyportion of the annuloplasty structure, and (2) a second portionextending away from the primary body portion of the annuloplastystructure, the contracting member being configured to adjust a perimeterof the annuloplasty structure.

The primary body portion of the annuloplasty structure can be shaped todefine a recess having a recess axis, the recess extending from anopening in a first surface of the lateral wall of the primary bodyportion toward an opposite second surface of the lateral wall of theprimary body portion, the lateral wall of the primary body portionextending away from the recess along a longitudinal axis that is at anon-zero angle with respect to the recess axis, the contracting memberextending through the recess and away from the primary body portion ofthe annuloplasty structure via the recess.

The system and/or apparatus can include a lock slidable along thecontracting member and toward the recess, the lock being fixedlycouplable to the contracting member in order to prevent movement of thecontracting member, the recess being shaped so as to facilitate fixedcoupling of the lock to the contracting member.

For some applications, the lock is disposable at least in part withinthe recess.

For some applications, the annuloplasty structure includes a fullannuloplasty ring structure; in others the annuloplasty structureincludes a partial annuloplasty ring structure.

For some applications, the lock is configured to lock the contractingmember when the lock is moved at least in part within the recess.

For some applications, the lock is configured to fit entirely within therecess.

For some applications the primary body portion includes a housing, thehousing defines at least a portion of the lateral wall, and the housingdefines the recess.

For some applications, the lock is shaped so as to define alock-threaded-portion, and the annuloplasty structure is shaped so as todefine an annuloplasty-structure-threaded-portion configured to engagewith the lock-threaded-portion.

For some applications, the recess defines a recess lumen extending alongthe recess axis. For some applications, the recess axis is disposed atthe non-zero angle.

For some applications the lock is shaped so as to define a slit whichextends from a proximal surface of the lock toward a distal surface ofthe lock, the lock defines a lock lumen of the lock extending from aproximal opening in the lock toward a distal opening in the lock, thelock lumen is configured to surround the contracting member, and whenthe lock is disposed within the recess, the slit enables the lock toclose around the contracting member and thereby lock the lock to thecontracting member.

For some applications, the recess is dimensioned so as to compress thelock when the lock is disposed at least in part within the recess.

For some applications, the slit is shaped so as to define a distalportion that is wider than a proximal portion of the slit.

For some applications, the lock lumen is shaped so as to define a distalportion that is wider than a proximal portion of the lock lumen.

For some applications, the recess is shaped so as to define aproximal-most portion that is narrower than any other portion of therecess distal to the proximal-most portion.

For some applications, the annuloplasty structure includes a housing,and the housing is shaped so as to define the recess, the recess havinga recess axis.

For some applications, the lock is shaped so as to define alock-threaded-portion, and the housing is shaped so as to define anannuloplasty-structure-threaded-portion configured to engage with thelock-threaded-portion.

For some applications, the housing is shaped so as to define acontracting-member lumen that is disposed at a non-zero angle withrespect to the recess axis.

For some applications, the housing is shaped so as to provide acontracting-member-lumen wall which is disposed along thecontracting-member lumen, and when the lock is disposed within therecess, a distal end of the lock is configured to pinch a first portionof the contracting member against the contracting-member-lumen wall inorder to lock the contracting member at least a first pinching point.

For some applications the recess is shaped so as to define arecess-distal-tapered-portion. For some applications, the lock is shapedso as to define a lock lumen of the lock extending from a proximalopening in the lock toward a distal opening in the lock, and alock-distal-tapered-portion. The lock lumen can be configured tosurround the contracting member.

For some applications, when the lock is disposed within the recess, therecess-distal-tapered-portion is configured to compress thelock-distal-tapered-portion which, in turn, is configured to pinch asecond portion of the contracting member within the lock lumen at therecess-distal-tapered-portion in order to lock the contracting member atleast a second pinching point.

For some applications, the system and/or apparatus further includes adelivery tool, the delivery tool and the contracting member beingslidable with respect to each other, the delivery tool being configuredto deliver the annuloplasty structure to an annulus of a heart of apatient.

For some applications, the delivery tool includes a knob coupled to aproximal portion of the contracting member, the knob being configured toincrease tension of the contracting member by pulling the contractingmember proximally.

For some applications, the knob is fixedly coupled to the proximalportion of the contracting member.

For some applications, when the delivery tool is coupled to theannuloplasty structure, a portion of the contracting member is disposedwithin a lumen of the delivery tool and the lock surrounds a part of thecontracting member.

For some applications, when the delivery tool is coupled to theannuloplasty structure, the lock is disposed at least in part within therecess.

For some applications, when the delivery tool is coupled to theannuloplasty structure, the lock is disposed entirely proximally to therecess.

For some applications, the delivery tool includes a lock-ejector movablewithin a distal end portion of the delivery tool, and movement of thelock-ejector contacts and converts the lock from an open state to aclosed state to clamp onto the contracting member passed therethrough.

For some applications, the distal end portion of the delivery tool isshaped so as to define a sharp edge, and the contracting member isdisposed in proximity to the sharp edge such that movement of thelock-ejector against the sharp edge severs the contracting memberextending through the lock.

There is further provided, in accordance with some applications, asystem and/or an apparatus, including an implantable annuloplastystructure including a primary body portion and a contracting member. Thecontracting member can be the same as or similar to other contractingmembers herein and can, for example, have a (1) first portion extendingalong a longitudinal length of the primary body portion of theannuloplasty structure, and a (2) second portion extending away from theprimary portion of the annuloplasty structure. The system and/orapparatus can include a lock slidable along the contracting member, thelock being fixedly couplable to the contracting member in order toprevent movement of the contracting member. The lock can be shaped so asto define a slit which extends from a proximal surface of the locktoward a distal surface of the lock.

For some applications, the lock defines a lock lumen of the lockextending from a proximal opening in the lock toward a distal opening inthe lock. The lock lumen can be configured to surround the contractingmember. When the lock is compressed, the slit can enable the lock toclose around the contracting member and thereby lock the lock to thecontracting member.

For some applications, the annuloplasty structure includes a fullannuloplasty ring structure, in others, the annuloplasty structureincludes a partial annuloplasty ring structure.

For some applications, the annuloplasty structure is shaped so as todefine a recess dimensioned so as to compress the lock when the lock isdisposed at least in part within the recess.

For some applications, the lock is disposable at least in part withinthe recess.

For some applications, the lock is configured to fit entirely within therecess.

For some applications, the slit is shaped so as to define a distalportion that is wider than a proximal portion of the slit.

For some applications, the lock lumen is shaped so as to define a distalportion that is wider than a proximal portion of the lock lumen.

For some applications, the recess is shaped so as to define a proximalportion that is narrower than any other portion of the recess distal tothe proximal portion.

For some applications, the lock is shaped so as to define alock-threaded-portion, and the annuloplasty structure is shaped so as todefine an annuloplasty-structure-threaded-portion configured to engagewith the lock-threaded-portion.

For some applications, the annuloplasty structure includes a housing,and the housing is shaped so as to define the recess, the recess havinga recess axis.

For some applications, the lock is shaped so as to define alock-threaded-portion, and the housing is shaped so as to define anannuloplasty-structure-threaded-portion configured to engage with thelock-threaded-portion.

For some applications, the housing is shaped so as to define acontracting-member lumen that is disposed at a non-zero angle withrespect to the recess axis.

For some applications, the housing is shaped so as to provide acontracting-member-lumen wall which is disposed along thecontracting-member lumen, and when the lock is disposed within therecess, a distal end of the lock is configured to pinch a first portionof the contracting member against the contracting-member-lumen wall inorder to lock the contracting member at least a first pinching point.

For some applications the recess is shaped so as to define arecess-distal-tapered-portion, and the lock is shaped so as to define alock lumen of the lock extending from a proximal opening in the locktoward a distal opening in the lock, and a lock-distal-tapered-portion.The lock lumen can be configured to surround the contracting member.When the lock is disposed within the recess, therecess-distal-tapered-portion can be configured to compress thelock-distal-tapered-portion which, in turn, is configured to pinch asecond portion of the contracting member within the lock lumen at therecess-distal-tapered-portion in order to lock the contracting member atleast a second pinching point.

For some applications, the system and/or apparatus further includes adelivery tool, the delivery tool and the contracting member beingslidable with respect to each other, the delivery tool being configuredto deliver the annuloplasty structure to an annulus of a heart of apatient.

For some applications, the delivery tool includes a knob coupled to aproximal portion of the contracting member, the knob being configured toincrease tension of the contracting member by pulling the contractingmember proximally.

For some applications, the knob is fixedly coupled to the proximalportion of the contracting member.

For some applications, when the delivery tool is coupled to theannuloplasty structure, a portion of the contracting member is disposedwithin a lumen of the delivery tool and the lock surrounds a part of thecontracting member.

For some applications, the annuloplasty structure is shaped so as todefine a recess dimensioned so as to compress the lock when the lock isdisposed at least in part within the recess, and when the delivery toolis coupled to the annuloplasty structure, the lock is disposed at leastin part within the recess.

For some applications, the annuloplasty structure is shaped so as todefine a recess dimensioned so as to compress the lock when the lock isdisposed at least in part within the recess, and when the delivery toolis coupled to the annuloplasty structure, the lock is disposed entirelyproximally to the recess.

For some applications, the delivery tool includes a lock-ejector movablewithin a distal end portion of the delivery tool, and movement of thelock-ejector contacts and converts the lock from an open state to aclosed state to clamp onto the contracting member passed therethrough.

For some applications, the distal end portion of the delivery tool isshaped so as to define a sharp edge, and the contracting member isdisposed in proximity to the sharp edge such that movement of thelock-ejector against the sharp edge severs the contracting memberextending through the lock.

There is further provided, in accordance with some applications, amethod, including advancing toward a heart of a patient an implantableannuloplasty structure. The implantable annuloplasty structure can bethe same as or similar to other annuloplasty structures herein orotherwise known, such as for example, having a primary body portionhaving a lateral wall and a contracting member having (1) a firstportion extending along a longitudinal length of the primary bodyportion of the annuloplasty structure, and (2) a second portionextending away from the primary body portion of the annuloplastystructure, the contracting member being configured to adjust a perimeterof the annuloplasty structure.

The primary body portion of the annuloplasty structure can be shaped todefine a recess having a recess axis, the recess extending from anopening in a first surface of the lateral wall of the primary bodyportion toward an opposite second surface of the lateral wall of theprimary body portion, the lateral wall of the primary body portionextending away from the recess along a longitudinal axis that is at anon-zero angle with respect to the recess axis, the contracting memberextending through the recess and away from the primary body portion ofthe annuloplasty structure via the recess; and

The method can further include locking the contracting member by slidinga lock along the contracting member to fit within the recess, the lockbeing fixedly couplable to the contracting member in order to preventmovement of the contracting member, the recess being shaped so as tofacilitate fixed coupling of the lock to the contracting member.

For some applications, advancing includes advancing the annuloplastystructure while the lock is disposed at least in part within the recess.

For some applications, advancing includes advancing the annuloplastystructure while the lock is disposed entirely proximally to the recess.

For some applications, locking the contracting member includes slidingthe lock fully within the recess.

For some applications, the annuloplasty structure includes a fullannuloplasty ring structure or a partial annuloplasty ring structure.

For some applications the lock is shaped so as to define a slit whichextends from a proximal surface of the lock toward a distal surface ofthe lock, the lock defines a lock lumen of the lock extending from aproximal opening in the lock toward a distal opening in the lock, thelock lumen is configured to surround the contracting member, and whenthe lock is disposed within the recess, the slit enables the lock toclose around the contracting member and thereby lock the lock to thecontracting member.

For some applications, the recess is dimensioned so as to compress thelock when the lock is disposed at least in part within the recess, andlocking includes positioning the lock at least in part within the recessso as to compress the lock.

For some applications, the lock lumen is shaped so as to define a distalportion that is wider than a proximal portion of the lock lumen.

For some applications, the recess is shaped so as to define a proximalportion that is narrower than any other portion of the recess distal tothe proximal portion.

For some applications, advancing includes advancing the annuloplastystructure using a delivery tool, and the method further includes slidingthe delivery tool and the contracting member with respect to each other.

For some applications, advancing includes advancing the lock within thedelivery tool and locking includes sliding the lock using the deliverytool.

For some applications, the delivery tool includes a knob coupled to aproximal portion of the contracting member, and the method furtherincludes using the knob, increasing tension of the contracting member bypulling the contracting member proximally.

For some applications, the knob is fixedly coupled to the proximalportion of the contracting member.

For some applications, the delivery tool includes a lock-ejector movablewithin a distal end portion of the delivery tool, and the method furtherincludes clamping the lock onto the contracting member passedtherethrough by moving the lock-ejector to contact and convert the lockfrom an open state to a closed state.

For some applications the distal end portion of the delivery tool isshaped so as to define a sharp edge, the contracting member is disposedin proximity to the sharp edge, moving the lock-ejector includes movingthe lock-ejector against the sharp edge, and severing the contractingmember extending through the lock by the moving of the lock-ejectoragainst the sharp edge.

The method can be performed in a procedure on a living animal or in asimulation/simulated procedure (e.g., on a cadaver, cadaver heart,simulator with a simulated heart, tissue, etc., anthropomorphic ghost,etc.).

There is further provided, in accordance with some applications, amethod, including advancing toward a heart of a patient an implantableannuloplasty structure. The annuloplasty structure can be the same as orsimilar to other annuloplasty structures herein or otherwise known, andcan, for example, include a primary body portion having a lateral walland a contracting member. The contracting member can have (1) a firstportion extending along a longitudinal length of the primary bodyportion of the annuloplasty structure, and (2) a second portionextending away from the primary body portion of the annuloplastystructure, the contracting member being configured to adjust a perimeterof the annuloplasty structure.

The method further includes locking the contracting member by sliding alock along the contracting member, the lock being fixedly couplable tothe contracting member in order to prevent movement of the contractingmember. The lock can be shaped so as to define a slit which extends froma proximal surface of the lock toward a distal surface of the lock. Thelock can define a lock lumen of the lock extending from a proximalopening in the lock toward a distal opening in the lock. The lock lumencan be configured to surround the contracting member. For someapplications, when the lock is compressed, the slit enables the lock toclose around the contracting member and thereby lock the lock to thecontracting member.

For some applications, the annuloplasty structure includes a fullannuloplasty ring structure or a partial annuloplasty ring structure.

For some applications, the annuloplasty structure is shaped so as todefine a recess dimensioned so as to compress the lock when the lock isdisposed at least in part within the recess, and locking the contractingmember includes sliding the lock at least in part within the recess.

For some applications, advancing includes advancing the annuloplastystructure while the lock is disposed at least in part within the recess.

For some applications, advancing includes advancing the annuloplastystructure while the lock is disposed entirely proximally to the recess.

For some applications, locking the contracting member includes slidingthe lock fully within the recess.

For some applications, the recess is dimensioned so as to compress thelock when the lock is disposed at least in part within the recess.

For some applications, the lock lumen is shaped so as to define a distalportion that is wider than a proximal portion of the lock lumen.

For some applications, the recess is shaped so as to define a proximalportion that is narrower than any other portion of the recess distal tothe proximal portion.

For some applications, advancing includes advancing the annuloplastystructure using a delivery tool, and the method further includes slidingthe delivery tool and the contracting member with respect to each other.

For some applications, advancing includes advancing the lock within thedelivery tool and locking includes sliding the lock using the deliverytool.

For some applications, the delivery tool includes a knob coupled to aproximal portion of the contracting member, and the method furtherincludes using the knob, increasing tension of the contracting member bypulling the contracting member proximally.

For some applications, the knob is fixedly coupled to the proximalportion of the contracting member.

For some applications, the delivery tool includes a lock-ejector movablewithin a distal end portion of the delivery tool, and the method furtherincludes clamping the lock onto the contracting member passedtherethrough by moving the lock-ejector to contact and convert the lockfrom an open state to a closed state.

For some applications the distal end portion of the delivery tool isshaped so as to define a sharp edge, the contracting member is disposedin proximity to the sharp edge, moving the lock-ejector includes movingthe lock-ejector against the sharp edge, and severing the contractingmember extending through the lock by the moving of the lock-ejectoragainst the sharp edge.

The method can be performed in a procedure on a living animal or in asimulation/simulated procedure (e.g., on a cadaver, cadaver heart,simulator with a simulated heart, tissue, etc., anthropomorphic ghost,etc.)

There is further provided, in accordance with some applications, asystem and/or an apparatus, including an implantable annuloplastystructure including a primary body portion and a contracting member. Thecontracting member can be the same as or similar to other contractingmembers herein or otherwise known, and can, for example, have (1) afirst portion extending along a longitudinal length of the primary bodyportion of the annuloplasty structure, and (2) a second portionextending away from the primary portion of the annuloplasty structure.

The system and/or apparatus further comprising at least onecontracting-member-fastener configured to surround the contractingmember. the contracting-member-fastener can include a clamping structurethat (a) is biased toward assuming a closed state, in the closed state,the clamping structure is configured to clamp onto the contractingmember passed therethrough, and (b) can be flexed to an open statethrough which the contracting member can move.

The system and/or apparatus further comprising a stop removably coupledto the contracting-member-fastener and configured to maintain thecontracting-member-fastener in the open state and acontracting-member-severing tool. The contracting-member-severing toolcan include a static cutting element having a first cutting surface, adynamic cutting element having a second cutting surface that opposes thefirst cutting surface, and one or more graspers configured to pull thestop proximally and remove the stop from thecontracting-member-fastener. For some applications, a portion of thecontracting member passes through the static cutting element and throughthe dynamic cutting element, and once pulled proximally, the stopcontacts the cutting element and is configured to push against and movethe dynamic cutting element with respect to the static cutting elementin order to facilitate severing of the contracting member.

For some applications, the first and second cutting surfaces are eachconcave. For some applications, the first and second cutting surfacesare each diagonal.

For some applications, the tool is arranged such that the tool providesa safety mechanism whereby movement of the dynamic cutting element withrespect to the static cutting element is possible only with pushing ofthe stop against the dynamic cutting element.

For some applications, the system and/or apparatus further includes ahousing that houses the fastener and the stop, and the tool is coupledto the housing as the graspers grasp the stop.

For some applications, the tool is configured to deliver the housing,the fastener, and the stop to the implantable annuloplasty structure.

For some applications, the implantable annuloplasty structure includesthe housing.

For some applications, the stop is shaped so as to define an overhang,and the graspers are configured to grip the overhang in order toinitially couple the tool to the fastener.

For some applications, the system and/or apparatus further includes anouter sleeve portion configured to surround the graspers in order tolock the graspers with respect to the overhang.

There is further provided, in accordance with some applications, asystem and/or an apparatus, including a contracting-member fastenerconfigured to fasten to a contracting member. For some applications, atleast one contracting-member-fastener is configured to surround thecontracting member. The contracting-member-fastener can include aclamping structure that (a) is biased toward assuming a closed state, inthe closed state, the clamping structure is configured to clamp onto thecontracting member passed therethrough, and (b) can be flexed to an openstate through which the contracting member can move.

The system and/or apparatus can include a stop removably coupled to thecontracting-member-fastener and configured to maintain thecontracting-member-fastener in the open state.

The system and/or apparatus can include a contracting-member-severingtool. The contracting-member-severing tool can include a cutting elementconfigured to cut the contracting member and one or more graspersconfigured to pull the stop proximally and remove the stop from thecontracting-member-fastener. For some applications, once pulledproximally, the stop contacts the cutting element and is configured topush against and move the cutting element in order to facilitatesevering of the contracting member by the cutting element.

For some applications, the tool is arranged such that the tool providesa safety mechanism whereby movement of the cutting element is possibleonly with pushing of the stop against the cutting element.

For some applications, the system and/or apparatus further includes ahousing that houses the fastener and the stop, and the tool is coupledto the housing as the graspers grasp the stop.

For some applications, the system and/or apparatus further includes animplantable annuloplasty structure, the tool is configured to deliverthe housing, the fastener, and the stop to the implantable annuloplastystructure.

For some applications, the system and/or apparatus further includes animplantable annuloplasty structure, the implantable annuloplastystructure includes the housing.

For some applications, the stop is shaped so as to define an overhang,and the graspers are configured to grip the overhang in order toinitially couple the tool to the fastener.

For some applications, the system and/or apparatus further includes anouter sleeve portion configured to surround the graspers in order tolock the graspers with respect to the overhang.

There is further provided, in accordance with some applications, amethod, including threading a contracting-member-severing tool along acontracting member, the contracting-member-severing tool including acutting element in proximity with the contracting member during thethreading. The method can also include engaging the tool with a stopthat is removably coupled to a contracting-member-fastener surrounding aportion of the contracting member, the stop being configured to maintainthe contracting-member-fastener in an open state.

For some applications, the method further includes using the tool,disengaging the stop from the contracting-member-fastener by pulling thestop with the tool, and by the pulling, contacting the stop with thecutting element and facilitating pushing of the stop against the cuttingelement, and by the pushing, facilitating moving of the cutting element,and thereby facilitating severing of the contracting member by thecutting element.

For some applications, the tool is arranged such that the tool providesa safety mechanism whereby the moving of the cutting element is possibleonly by the pushing of the stop against the cutting element.

For some applications, the method further includes a housing that housesthe fastener and the stop, and the method includes coupling the tool tothe housing by gasping the stop with the tool.

For some applications, the method further includes, using the tool,delivering the housing, the fastener, and the stop to an implantableannuloplasty structure.

For some applications, coupling the tool to the housing includescoupling the tool the housing that is coupled to an implantableannuloplasty structure.

For some applications, the stop is shaped so as to define an overhang,and engaging the tool with a stop includes initially coupling the toolto the fastener by gripping the overhang with the tool with graspers.

For some applications, the method further includes locking the grasperswith respect to the overhang by passing an outer sleeve portion over thegraspers.

The method can be performed in a procedure on a living animal or in asimulation/simulated procedure (e.g., on a cadaver, cadaver heart,simulator with a simulated heart, tissue, etc., anthropomorphic ghost,etc.)

There is further provided, in accordance with some applications, asystem and/or an apparatus including an implant including an implantablestructure and a flexible elongated contracting member that extends awayfrom the implantable structure; and a contracting-member-uptake tool,which includes a handle portion, which includes an outer housing, atubular shaft, disposed at least partially within the outer housing, andan inner shaft.

For some application, the inner shaft (a) is partially disposed within aproximal longitudinal portion of the tubular shaft, such that the innershaft is axially slidable with respect to the tubular shaft, (b) isshaped so as to define an inner-shaft contracting-member-receivingchannel, and (c) includes a lock, which is configured (i) when in anunlocked state, to allow sliding of the contracting member with respectto the inner-shaft contracting-member-receiving channel, and (ii) whenin a locked state, to axially lock the contracting member with respectto the inner shaft.

For some applications, the system and/or apparatus (e.g., in the handle)further includes a distal force applicator, which (a) is disposed atleast partially within a distal longitudinal portion of the tubularshaft, and (b) is shaped so as to define a distal-force-applicatorcontracting-member-receiving channel, which allows sliding of thecontracting member therethrough.

For some applications, the system and/or apparatus (e.g., in the handle)further includes a spring, which is disposed within the tubular shaft,connecting the distal force applicator and a distal portion of the innershaft; and a contraction-facilitating knob, which is accessible fromoutside the outer housing,

For some applications, the handle portion is shaped so as to define ahandle contracting-member-receiving channel from a distal end through toa proximal end of the handle portion, the handlecontracting-member-receiving channel includes the inner-shaftcontracting-member-receiving channel and the distal-force-applicatorcontracting-member-receiving channel,

For some applications, the handle portion is configured such thatactuation of the contraction-facilitating knob, when the contractingmember is disposed passing entirely through the handlecontracting-member-receiving channel and the lock is in the lockedstate, causes the handle portion to uptake successive portions of thecontracting member by advancing the tubular shaft proximally withrespect to the outer housing, which advances the distal force applicatorproximally with respect to the outer housing, which applies aproximally-directed force to the spring, which pushes the inner shaftproximally with respect to the outer housing, and which proximally pullsthe contracting member.

For some applications, the handle portion is configured such that uponthe actuation of the contraction-facilitating knob when the contractingmember is disposed passing entirely through the handlecontracting-member-receiving channel, the lock is in the locked state,and the contracting member is tensed: the spring pushes the inner shaftproximally with respect to the outer housing to a lesser extent than thetubular shaft proximally advances with respect to the outer housing, andproximal pulling of the contracting member by the inner shaft increasestension in the contracting member.

For some applications, the contraction-facilitating knob is configuredto be actuated by rotation thereof.

For some applications, the tubular shaft and thecontraction-facilitating knob are in threaded connection with eachother, and the handle portion is configured such that actuation of thecontraction-facilitating knob rotates the tubular shaft, therebyadvancing the tubular shaft proximally with respect to the outerhousing.

For some applications, the inner shaft partially protrudes out of aproximal end of the outer housing, and the tubular shaft and the innershaft together provide a non-electrical mechanical force gauge, in whicha relative axial position of the tubular shaft with respect to the innershaft provides a visual indication of a measure of the tension in thecontracting member.

For some applications, the inner shaft is marked with a plurality offiduciary markers, which are arranged along the inner shaft to indicatethe relative axial position of the tubular shaft with respect to theinner shaft.

For some applications, the handle portion further includes atension-limiting locking assembly, which is configured to axially lockthe inner shaft with respect to the outer housing when the handleportion increases the tension in the contracting member to apredetermined threshold level, thereby limiting a maximum tension thatthe inner shaft can apply to the contracting member.

For some applications, the tension-limiting locking assembly isconfigured to axially lock the inner shaft with respect to the outerhousing when the tubular shaft is disposed at a predetermined relativeaxial position with respect to the inner shaft, thereby limiting themaximum tension that the inner shaft can apply to the contractingmember.

For some applications, the tension-limiting locking assembly includes adetent, which is arranged to axially lock the inner shaft with respectto the outer housing when the tubular shaft is disposed at thepredetermined relative axial position with respect to the inner shaft,thereby limiting the maximum tension that the inner shaft can apply tothe contracting member.

For some applications, the detent is coupled in axial fixation with theinner shaft and is configured to move radially outward so as to engagethe outer housing in order to axially lock the inner shaft with respectto the outer housing.

For some applications, the tension-limiting locking assembly furtherincludes a plurality of indentations that the outer housing is shaped soas to define, the detent is engageable with the indentations to axiallylock the inner shaft with respect to the outer housing, and the handleportion is arranged such that the particular one of the indentationswith which the detent engages depends upon a relative axial position ofthe inner shaft with respect to the outer housing when the tubular shaftis disposed at the predetermined relative axial position with respect tothe inner shaft.

For some applications, the proximal longitudinal portion of the tubularshaft is shaped so as to define an elongate opening through which thedetent passes when the detent axially locks the inner shaft with respectto the outer housing.

For some applications, the tubular shaft includes one or more tracksthat run alongside a longitudinal portion of the elongate opening andare arranged to:

-   -   (a) prevent the detent from axially locking the inner shaft with        respect to the outer housing when the tubular shaft is disposed        distally to the predetermined relative axial position with        respect to the inner shaft, and    -   (b) allow the detent to axially lock the inner shaft when the        tubular shaft is disposed at the predetermined relative axial        position with respect to the inner shaft.

For some applications, the one or more tracks are shaped so as to defineone or more respective sloping portions, such that after the detentaxially locks the inner shaft with respect to the outer housing when thetubular shaft is disposed at the predetermined relative axial positionwith respect to the inner shaft, subsequent distal motion of the tubularshaft and consequently the one or more tracks with respect to the innershaft disengages the detent from the outer housing.

For some applications, the inner shaft partially protrudes out of aproximal end of the outer housing, and the tubular shaft and the innershaft together provide a non-electrical mechanical force gauge, in whicha relative axial position of the tubular shaft with respect to the innershaft provides a visual indication of a measure of the tension in thecontracting member.

For some applications, the implantable structure includes an implantableannuloplasty structure.

For some applications, the implantable annuloplasty structure includes aflexible sleeve, and the contracting member extends along and away fromthe sleeve.

There is further provided, in accordance with some applications, asystem and/or an apparatus includes an implant including an implantablestructure and a flexible elongated contracting member that extends awayfrom the implantable structure; and a contracting-member-uptake tool.The contracting-member-uptake tool can include a handle portion, which(a) is shaped so as to define a handle contracting-member-receivingchannel from a distal end through to a proximal end of the handleportion, and (b) includes: an outer housing; a non-electrical mechanicalforce gauge; a lock; and a contraction-facilitating knob, which isaccessible from outside the outer housing. The lock can be configured(i) when in an unlocked state, to allow sliding of the contractingmember with respect to the force gauge, and (ii) when in a locked state,to axially lock the contracting member with respect to anaxially-movable portion of the force gauge, the axially-movable portionof the force gauge is axially-movable with respect to the outer housing.

For some applications, the handle portion is configured such thatactuation of the contraction-facilitating knob, when the contractingmember is disposed passing entirely through the handlecontracting-member-receiving channel and the lock is in the lockedstate, causes the handle portion to uptake successive portions of thecontracting member by advancing the force gauge proximally with respectto the outer housing so as to proximally pull the contracting member.

For some applications, the handle portion is configured such that uponthe actuation of the contraction-facilitating knob when the contractingmember is disposed passing entirely through the handlecontracting-member-receiving channel, the lock is in the locked state,and the contracting member is tensed, proximal pulling of thecontracting member by the axially-movable portion of the force gaugeincreases tension in the contracting member, and the force gauge isconfigured to provide a visual indication of a measure of the tension inthe contracting member.

For some applications, the force gauge includes a spring.

For some applications, the force gauge is configured such that thespring applies a proximally-directed force to the axially-movableportion of the force gauge.

For some applications, the handle portion further includes atension-limiting locking assembly, which is configured to axially lockthe axially-movable portion of the force gauge with respect to the outerhousing when the handle portion increases the tension in the contractingmember to a predetermined threshold level, thereby limiting a maximumtension that the axially-movable portion of the force gauge can apply tothe contracting member.

There is further provided, in accordance with some applications, amethod including advancing toward a heart of a patient an implantablestructure of an implant and a flexible elongated contracting member thatextends away from the implantable structure, and threading a portion ofthe contracting member through a handle contracting-member-receivingchannel of a handle portion of a contracting-member-uptake tool. Thecontracting-member-uptake tool can be the same as or similar to othercontracting-member-uptake tools described elsewhere herein, and can, forexample, include one, all, or some of an outer housing, a tubular shaft,disposed at least partially within the outer housing, an inner shaft, adistal force applicator, a spring, and a contraction-facilitating knob,which is accessible from outside the outer housing.

The inner shaft can (a) be partially disposed within a proximallongitudinal portion of the tubular shaft, such that the inner shaft isaxially slidable with respect to the tubular shaft, (b) be shaped so asto define an inner-shaft contracting-member-receiving channel, and (c)include a lock, which is configured (i) when in an unlocked state, toallow sliding of the contracting member with respect to the inner-shaftcontracting-member-receiving channel, and (ii) when in a locked state,to axially lock the contracting member with respect to the inner shaft.

The distal force applicator can (a) be disposed at least partiallywithin a distal longitudinal portion of the tubular shaft, and (b) beshaped so as to define a distal-force-applicatorcontracting-member-receiving channel, which allows sliding of thecontracting member therethrough, the handle contracting-member-receivingchannel (a) extends from a distal end through to a proximal end of thehandle portion, and (b) includes the inner-shaftcontracting-member-receiving channel and the distal-force-applicatorcontracting-member-receiving channel.

The spring can be disposed within the tubular shaft, connecting thedistal force applicator and a distal portion of the inner shaft.

The method further includes transitioning the lock from the unlockedstate to the locked state.

For some applications, the method includes, thereafter, actuating thecontraction-facilitating knob to cause the handle portion to uptakesuccessive portions of the contracting member until the contractingmember is tensed, by: advancing the tubular shaft proximally withrespect to the outer housing, which advances the distal force applicatorproximally with respect to the outer housing, which applies aproximally-directed force to the spring, which pushes the inner shaftproximally with respect to the outer housing, which proximally pulls thecontracting member; and thereafter, once the contracting member istensed, actuating the contraction-facilitating knob to increase tensionin the contracting member by proximal pulling of the contracting memberby the inner shaft caused by the spring pushing the inner shaftproximally with respect to the outer housing to a lesser extent than thetubular shaft proximally advances with respect to the outer housing.

For some applications, actuating the contraction-facilitating knobincludes rotating the contraction-facilitating knob.

For some applications, the tubular shaft and thecontraction-facilitating knob are in threaded connection with eachother, and the handle portion is configured such that actuation of thecontraction-facilitating knob rotates the tubular shaft, therebyadvancing the tubular shaft proximally with respect to the outerhousing.

For some applications, the inner shaft partially protrudes out of aproximal end of the outer housing, the tubular shaft and the inner shafttogether provide a non-electrical mechanical force gauge, in which arelative axial position of the tubular shaft with respect to the innershaft provides a visual indication of a measure of the tension in thecontracting member, and the method further includes viewing the visualindication.

For some applications, the inner shaft is marked with a plurality offiduciary markers, which are arranged along the inner shaft to indicatethe relative axial position of the tubular shaft with respect to theinner shaft.

For some applications, the handle portion further includes atension-limiting locking assembly, which is configured to axially lockthe inner shaft with respect to the outer housing when the handleportion increases the tension in the contracting member to apredetermined threshold level, thereby limiting a maximum tension thatthe inner shaft can apply to the contracting member.

For some applications, the tension-limiting locking assembly isconfigured to axially lock the inner shaft with respect to the outerhousing when the tubular shaft is disposed at a predetermined relativeaxial position with respect to the inner shaft, thereby limiting themaximum tension that the inner shaft can apply to the contractingmember.

For some applications, the tension-limiting locking assembly includes adetent, which is arranged to axially lock the inner shaft with respectto the outer housing when the tubular shaft is disposed at thepredetermined relative axial position with respect to the inner shaft,thereby limiting the maximum tension that the inner shaft can apply tothe contracting member.

For some applications, the detent is coupled in axial fixation with theinner shaft and is configured to move radially outward so as to engagethe outer housing in order to axially lock the inner shaft with respectto the outer housing.

For some applications, the tension-limiting locking assembly furtherincludes a plurality of indentations that the outer housing is shaped soas to define, the detent is engageable with the indentations to axiallylock the inner shaft with respect to the outer housing, and the handleportion is arranged such that the particular one of the indentationswith which the detent engages depends upon a relative axial position ofthe inner shaft with respect to the outer housing when the tubular shaftis disposed at the predetermined relative axial position with respect tothe inner shaft.

For some applications, the proximal longitudinal portion of the tubularshaft is shaped so as to define an elongate opening through which thedetent passes when the detent axially locks the inner shaft with respectto the outer housing.

For some applications, the tubular shaft includes one or more tracksthat run alongside a longitudinal portion of the elongate opening andare arranged to:

-   -   (a) prevent the detent from axially locking the inner shaft with        respect to the outer housing when the tubular shaft is disposed        distally to the predetermined relative axial position with        respect to the inner shaft, and    -   (b) allow the detent to axially lock the inner shaft when the        tubular shaft is disposed at the predetermined relative axial        position with respect to the inner shaft.

For some applications, the one or more tracks are shaped so as to defineone or more respective sloping portions, such that after the detentaxially locks the inner shaft with respect to the outer housing when thetubular shaft is disposed at the predetermined relative axial positionwith respect to the inner shaft, subsequent distal motion of the tubularshaft and consequently the one or more tracks with respect to the innershaft disengages the detent from the outer housing.

For some applications, the inner shaft partially protrudes out of aproximal end of the outer housing, the tubular shaft and the inner shafttogether provide a non-electrical mechanical force gauge, in which arelative axial position of the tubular shaft with respect to the innershaft provides a visual indication of a measure of the tension in thecontracting member, and the method further includes viewing the visualindication.

For some applications, the implantable structure includes an implantableannuloplasty structure, and advancing the implantable structure includesadvancing the implantable annuloplasty structure toward the heart.

For some applications, the implantable annuloplasty structure includes aflexible sleeve, and advancing the implantable annuloplasty structureand the contracting member toward the heart such that the contractingmember extends along and away from the sleeve.

There is further provided, in accordance with some applications, amethod including advancing toward a heart of a patient an implantablestructure of an implant and a flexible elongated contracting member thatextends away from the implantable structure, and threading a portion ofthe contracting member through a handle contracting-member-receivingchannel of a handle portion of a contracting-member-uptake tool.

The contracting-member-uptake tool can be the same as or similar toother contracting-member-uptake tools described elsewhere herein orotherwise known. For example, in some applications, thecontracting-member-uptake tool comprises an outer housing, anon-electrical mechanical force gauge, a lock, and acontraction-facilitating knob. The lock can be configured (i) when in anunlocked state, to allow sliding of the contracting member with respectto the force gauge, and (ii) when in a locked state, to axially lock thecontracting member with respect to an axially-movable portion of theforce gauge, the axially-movable portion of the force gauge isaxially-movable with respect to the outer housing. Thecontraction-facilitating knob can be accessible from outside the outerhousing.

The method further includes transitioning the lock from the unlockedstate to the locked state; and thereafter, actuating thecontraction-facilitating knob to cause the handle portion to uptakesuccessive portions of the contracting member by advancing the forcegauge proximally with respect to the outer housing so as to proximallypull the contracting member.

The method can thereafter include, once the contracting member istensed, actuating the contraction-facilitating knob to increase tensionin the contracting member by proximal pulling of the contracting memberby the axially-movable portion of the force gauge, and viewing a visualindication of a measure of the tension in the contracting member, thevisual indication provided by the force gauge.

For some applications, the force gauge includes a spring.

For some applications, the force gauge is configured such that thespring applies a proximally-directed force to the axially-movableportion of the force gauge.

For some applications, the handle portion further includes atension-limiting locking assembly, which is configured to axially lockthe axially-movable portion of the force gauge with respect to the outerhousing when the handle portion increases the tension in the contractingmember to a predetermined threshold level, thereby limiting a maximumtension that the axially-movable portion of the force gauge can apply tothe contracting member.

The method can be performed in a procedure on a living animal or in asimulation/simulated procedure (e.g., on a cadaver, cadaver heart,simulator with a simulated heart, tissue, etc., anthropomorphic ghost,etc.)

There is also provided, in accordance with some applications, a systemand/or an apparatus, which can include an implantable annuloplastystructure (e.g., an annuloplasty ring structure, a closed annuloplastystructure, a closed annuloplasty ring structure, an open annuloplastystructure, a partial annuloplasty ring structure, or other annuloplastydevice). The implantable annuloplasty structure can comprise a primarybody portion and a contracting member extending at least partially alonga longitudinal length of the primary body portion of the annuloplastystructure. The implantable annuloplasty structure can be the same as orsimilar to other annuloplasty structures described elsewhere herein.

The system and/or apparatus can also comprise acontracting-member-uptake tool. The contracting-member-uptake tool canbe the same as or similar to other contracting-member-uptake toolsdescribed elsewhere herein. The contracting-member-uptake tool cancomprise one or more tubes (e.g., one tube, a primary tube and asecondary tube, etc.). At least one tube has a lumen configured forpassage therethrough of the contracting member. The tube can beflexible, semi-rigid, or rigid. The contracting-member-uptake tool canalso comprise a contracting-member-snare. The contracting-member snarecan comprise a distal snare portion and an elongate flexible bodyportion coupled to the distal snare portion. The distal snare portioncan be configured to ensnare a portion of the contracting member andpull it into the lumen. The distal snare portion can be configured topull the portion of the contracting member through some of the lumen orthrough an entire length of the lumen (e.g., from end to end). Thecontracting-member-snare can comprise a wire comprising stainless steel.The lumen of the tube can be sized so as to maintain coupling betweenthe distal snare portion and the contracting member.

The contracting-member-uptake tool can comprise a handle portion, andthe tube can be connected to the handle portion. The handle portion cancomprise a contracting-member-uptake device configured to uptakesuccessive portions of the contracting member. The handle portion canalso include a tension meter configured to measure a degree of tensionof the contracting member. The contracting-member-uptake device can beactuatable to increase tension of the contracting member. Thecontracting-member-uptake device can optionally comprise a wheel havinga groove configured to couple the contracting member to the wheel. Thegroove can be shaped so as to receive a middle portion of thecontracting member.

The distal snare portion can comprise a flexible loop. The lumen can beconfigured to collapse the flexible loop around the contracting memberas the portion of the contracting member is pulled through the lumen. Atleast the distal snare portion of the contracting-member-snare can becorrugated to increase friction between the snare portion and thecontracting member.

The distal end portion of the contracting-member-uptake tool can beshaped so as to define a sharp edge, and the contracting member-uptaketool can be configured to dispose the contracting member in proximity tothe sharp edge such that the sharp edge can sever the contractingmember.

The contracting member-uptake tool can comprise acontracting-member-fastener disposed within the distal end portion ofthe contracting-member-uptake tool. The contracting-member-fastener cancomprise a clamping structure. The clamping structure can be biasedtoward assuming a closed state or closed position, and in the closedstate/position, the clamping structure can be configured to clamp ontothe contracting member passed therethrough. The clamping structure canalso be configured such that it can be flexed to an open state or openposition, wherein in the open state/position, the contracting member canmove therethrough. The contracting member-uptake tool can also comprisea stop removably coupled to the contracting-member-fastener andconfigured to maintain the contracting-member-fastener in the openstate/position.

The distal snare portion, the portion of the contracting-member, and theclamping structure can be configured and sized to pass distally throughthe contracting-member-fastener and clamping structure in the openstate/position. The distal snare portion can be adapted to capture andpull the portion of the contracting member proximally through thecontracting-member-fastener and clamping structure, and through alignedports in the distal end portion of the contracting-member-uptake tool.

The contracting-member-uptake tool can comprise a fastener-ejectormovable within the distal end portion of the contracting-member-uptaketool, which can be configured such that movement of the fastener-ejectorcontacts and can convert the contracting-member-fastener and clampingstructure from the open state/position to the closed state/position toclamp onto the contracting member when passed therethrough. Thefastener-ejector can be coupled to the stop and can be configured tomove the stop that is removably coupled to the fastener. The distal endportion of the contracting-member-uptake tool can be shaped so as todefine a sharp edge, and the contracting-member-uptake tool can beconfigured to dispose the contracting member in proximity to the sharpedge such that movement of the fastener-ejector against the sharp edgesevers the contracting member after or proximate where it extendsthrough the fastener.

The various apparatuses, systems, methods, etc. described above canincorporate and/or substitute various features and components of otherembodiments described elsewhere herein.

The present inventions will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-2 are schematic illustrations of an example of a multi-componenttubular system for delivering and anchoring an implant and forcontrolling a relative spatial orientation of components of the cathetersystem;

FIGS. 3A-I are schematic illustrations of an example procedure forimplanting an annuloplasty structure to repair a mitral valve;

FIGS. 4A-B are schematic illustrations of an examplecontracting-member-uptake tool which is configured to contract acontracting member of the annuloplasty structure of FIGS. 3A-I and severany excess portions of the contracting member;

FIGS. 5A-D are schematic illustrations of the examplecontracting-member-uptake tool of FIGS. 4A-B used to uptake thecontracting member;

FIGS. 6A-B are schematic illustrations of the examplecontracting-member-uptake tool of FIGS. 4A-B used to uptake thecontracting member in order to contract the annuloplasty structurecoupled to the contracting member;

FIGS. 7A-E are schematic illustrations of the examplecontracting-member-uptake tool of FIGS. 4A-B used to lock and secure theannuloplasty structure in its contracted state and subsequently, severexcess portions of the contracting member;

FIGS. 8A-D are schematic illustrations of an example of a system forcontracting the annulus of the patient using an annuloplasty structurecomprising a housing which houses a contracting-member-fastener;

FIGS. 9A-D are schematic illustrations of an examplecontracting-member-uptake tool used to lock and secure the annuloplastystructure of FIGS. 8A-D in its contracted state and subsequently, severexcess portions of the contracting member;

FIGS. 10A-B are schematic illustrations of an example of acontracting-member-uptake tool useable to engage a contracting memberand sever any excess portions of the contracting member;

FIGS. 11A-C are schematic illustrations of an example of acontracting-member-uptake tool used to lock and secure the annuloplastystructure in its contracted state and subsequently, sever excessportions of the contracting member;

FIGS. 12A-C are schematic illustrations of an example of a systemcomprising an example annuloplasty structure comprising a sleeve, acontracting member, and a lock;

FIGS. 13A-C are schematic illustrations of an example of a systemcomprising an example annuloplasty structure comprising a sleeve, acontracting member, and a lock;

FIG. 14 is a schematic illustration of an example lock useable to lock aperimeter of an annuloplasty structure;

FIGS. 15A-C are schematic illustrations of an example of a systemcomprising an example annuloplasty structure comprising a sleeve, acontracting member, and a lock;

FIG. 16 is a schematic illustration of an example of a system comprisingan example annuloplasty structure comprising a sleeve, a contractingmember, and a lock;

FIG. 17 is a schematic illustration of an example of a system comprisingan example annuloplasty structure comprising a sleeve, a contractingmember, and a lock;

FIG. 18 is a schematic illustration of an example of a system forcontracting the annulus of the patient using an annuloplasty structurecomprising a housing which houses a contracting-member-fastener;

FIGS. 19A-B are schematic illustrations of an example of a system forcontracting the annulus of the patient using an annuloplasty structurecomprising a housing which houses a contracting-member-fastener;

FIGS. 20A-F are schematic illustrations of an example of acontracting-member-uptake and contracting-member severing tool for usewith an annuloplasty structure comprising a housing which houses acontracting-member-fastener;

FIGS. 21A-B are schematic illustrations of an example of acontracting-member-uptake tool of the multi-component tubular system ofFIGS. 20A-F, before insertion of a flexible elongated contractingmember, in accordance with some applications;

FIGS. 22A-B are schematic illustrations of the contracting-member-uptaketool of FIGS. 21A-B after insertion of the flexible elongatedcontracting member, in accordance with some applications;

FIGS. 23A-B, 24A-B, and 25A-B are schematic illustrations of thecontracting-member-uptake tool of FIGS. 21A-B after successive levels ofactuation of a contraction-facilitating knob of the tool, in accordancewith some applications; and

FIGS. 26A-B are schematic illustrations of a portion of an outer housingand a tubular shaft of the contracting-member-uptake tool of FIGS.21A-B, in accordance with some applications.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is now made to FIGS. 1-2, which are schematic illustrations ofan example of a multi-component tubular system 10 providing one or morerotationally-controlled steering catheters configured for delivering animplant to a heart of a patient. System 10 provides an implant-deliverytool. System 10 can comprise a first, outer catheter 12 comprising asheath configured for advancement through vasculature of a patient. Forsome applications, outer catheter 12 comprises a sheath configured foradvancement through a femoral artery toward an interatrial septum of aheart of a patient. A distal steerable end portion of outer catheter 12is configured to pass through the septum and be oriented in a desiredspatial orientation. System 10 comprises a second catheter, or guidecatheter 14, comprising a steerable distal end portion. Catheter 14 isconfigured for advancement through a lumen of outer catheter 12. Outercatheter 12 provides a first coupling 152 (e.g., a slit 52) at a distalportion thereof (e.g., a portion of catheter 12 that is proximal to thesteerable distal end portion). Guide catheter 14 can comprise a secondcoupling 154 (e.g., a depressible engager 54) that is coupled to adisplaceable tab 56 coupled to a base. As is described herein,depressible engager 54 (or the second coupling 154) is configured so asto protrude within slit 52 (or the first coupling 152). Thus, slit 52defines a second-coupling-receiving element.

In some embodiments, first coupling 152 of catheter 12 defines a longercoupling, the second coupling 154 of catheter 14 defines a shortercoupling. The first and second couplings 152 and 154 of outer catheter12 and guide catheter 14, respectively, enable axial advancement androtational motion of guide catheter 14 through the lumen of outercatheter 12 until engager 54 of catheter 14 is aligned with and engagesslit 52 of catheter 12, as will be described hereinbelow. As shown incross-section A-A of FIG. 1, guide catheter 14 is configured to beconcentrically disposed within a lumen of outer catheter 12. In someembodiments, catheter 12 provides the shorter coupling, and catheter 14provides the longer coupling. For example, catheter 14 can be shaped soas to provide slit 52, and catheter 12 can comprise engager 54, which isconfigured to engage slit 52 of catheter 14.

As shown in the exploded view of view B, first coupling 152 can beshaped so as to define slit 52. For some applications, slit 52 isprovided by a metal frame 50, as shown. Metal frame 50 can have a lengthL22 of, for example, between 7 and 15 mm, e.g., 13 mm. For suchapplications, a slit is created in material of catheter 12 (e.g., bycreating a slit in the polymer material of catheter 12 duringmanufacturing of catheter 12), and frame 50 is coupled to catheter 12.Second coupling 154 can comprise an engager 54 which can comprise aprotrusion disposed at a distal portion of displaceable tab 56 of a baseof engager 54. The base of engager 54 can be shaped so as to defineslits 57 which form tab 56. Engager 54 is depressible when a force isapplied thereto, and tab 56 facilitates movement of engager 54 inresponse to and in the absence of force applied to engager 54. For someapplications, during manufacture of catheter 14, catheter 14 ismanipulated in order to couple thereto engager 54 and tabs 56, e.g.,engager 54 and tabs 56 are embedded within the polymer of catheter 14.

Although slit 52 and a depressible engager 54 are shown on outercatheter 12 and guide catheter 14, respectively, at distal portions ofcatheters 12 and 14, slit 52 and engager 54 can be provided along anysuitable portion of catheters 12 and 14, respectively (e.g., respectiveproximal portions of catheters 12 and 14).

First and second couplings 152 and 154, respectively, can be provided onany standard catheter. That is, coupling 152 comprises frame 50 whichcan be coupled to an external surface of any standard catheter (in whichcase, a corresponding slit would be made in the standard catheter).Additionally coupling 154 can be coupled to any standard catheter bycoupling the base portion of coupling 154 to any standard catheter.Suitable adjustments to the standard catheter would be made toaccommodate the displacing of tab 56 and engager 54 in response topushing forces applied to engager 54.

FIG. 2 shows an example concentric relationship between components oftubular system 10 (in an exploded view on the left side of FIG. 2). Asdescribed hereinabove, a distal end portion of outer catheter 12 issteerable. The distal end portion of outer catheter 12 can comprise apull ring 11 that is coupled to two or more steering or pull wires 29 aand 29 b, that are disposed within respective secondary lumens within awall of catheter 12 (as shown in section A-A). As shown in the explodedview, guide catheter 14 can be configured to be concentrically disposedwithin the lumen of catheter 12. As described hereinabove, the distalend portion of guide catheter 14 is steerable. The distal end portion ofcatheter 14 can comprise a pull ring 13 that is coupled to two or morepull wires 31 a and 31 b, that are disposed within respective secondarylumens within a wall of catheter 14 (as shown in sections A-A and B-B).

Guide catheter 14 is steerable to a desired spatial orientation in orderto facilitate advancing and implantation of an implant in a body cavityof the patient. As shown, the implant comprises an annuloplastystructure 222 (e.g., an annuloplasty ring structure, a closedannuloplasty structure, a closed annuloplasty ring structure, an openannuloplasty structure, a partial annuloplasty ring structure, etc.)comprising a flexible sleeve 26 (shown in the exploded view of FIG. 2).Sleeve 26 can comprise a braided fabric mesh, e.g., comprising DACRON™.Sleeve 26 can be configured to be placed only partially around a cardiacvalve annulus (i.e., to assume a C-shape), and, once anchored in place,to be contracted so as to circumferentially tighten the valve annulus.Although, the ring structure can also be configured to be placedentirely around the valve annulus. In order to tighten the annulus,annuloplasty structure or annuloplasty ring structure 222 comprises aflexible elongate contracting member 226 that extends along sleeve 26.Elongate contracting member 226 can comprise a wire, a ribbon, a rope,or a band, which can comprise one or more of a variety of materials, forexample, a flexible and/or superelastic material, e.g., nitinol,polyester, stainless steel, or cobalt chrome. For some applications, thewire comprises a radiopaque material. For some applications, contractingmember 226 comprises a braided polyester suture (e.g., Ticron). For someapplications, contracting member 226 is coated withpolytetrafluoroethylene (PTFE). For some applications, contractingmember 226 comprises a plurality of wires that are intertwined to form arope structure.

For applications in which system 10 is used to deliver an implant to themitral valve of the patient, outer catheter 12 can be configured forinitial advancement through vasculature of the patient until a distalend 102 (which can be a distal-most end or tip) of catheter 12 ispositioned in the left atrium. The distal steerable end portion ofcatheter 12 is then steered such that distal end 102 of catheter 12 ispositioned in a desired spatial orientation within the left atrium. Thesteering procedure can be performed with the aid of imaging, such asfluoroscopy, transesophageal echo, and/or echocardiography. Followingthe steering of the distal end portion of catheter 12, guide catheter 14(which houses annuloplasty structure 222) is advanced through catheter12 in order to facilitate delivery and implantation of structure 222along the annulus of the mitral valve. During the delivery, at least aportion of the steerable distal end portion of catheter 14 can beexposed from distal end 102 of catheter 12 and is thus free for steeringtoward the annulus of the mitral valve, as is described hereinbelow.

In addition, system 10 comprises an attachment mechanism (e.g.,anchor(s), adhesive, clamp(s), clip(s), fastener(s), etc.), such as aplurality of anchors 32, which can be, for example, between about ₅ andabout 20 anchors, such as about 10 or about 16 anchors. Each anchor 32can comprise a tissue-engaging element 60 (e.g., a helicaltissue-engaging element), and a tool-coupling head 62, fixed to one endof the tissue-engaging element. One anchor 32 is shown in FIG. 2 asbeing reversibly coupled to a deployment element 38 of a rotating anchordriver 36 of an anchor deployment manipulator 61. When sleeve 26 isdisposed along the annulus of the cardiac valve, deployment manipulator61 is configured to advance within a lumen of sleeve 26 and deploy eachanchor 32 from within sleeve 26 through a wall of sleeve 26 and intocardiac tissue, thereby anchoring sleeve 26 around a portion of thevalve annulus. The insertion of the anchors into the sleeve anddeployment of the anchors into cardiac tissue is described in detailhereinbelow.

Anchors 32 can comprise a biocompatible material, such as stainlesssteel 316 LVM. For some applications, anchors 32 comprise nitinol. Forsome applications, anchors 32 are coated fully or partially with anon-conductive material.

Deployment manipulator 61, as shown in FIG. 2, comprises anchor driver36 and deployment element 38.

As shown in the exploded view of FIG. 2, sleeve 26 is disposed within alumen of guide catheter 14. A force is applied to a proximal end ofsleeve 26 by a distal end of a reference-force tube 19. As shown, animplant-decoupling channel 18 is advanceable within a lumen ofreference-force tube 19 and through a lumen of sleeve 26 such that aportion of channel 18 that is disposed within the sleeve is coaxial withthe sleeve. As shown in the enlarged image of FIG. 1, a distal end 17 ofimplant-decoupling channel 18 is disposed in contact with an inner wallof sleeve 26 at a distal end thereof. Additionally, a distal end portionof channel 18 comprises a radiopaque marker 1018. As shown, tube 19 andsleeve 26 are longitudinally and coaxially disposed with respect to eachother.

Anchor driver 36 can be advanced within channel 18. For someapplications, system 10 comprises a plurality of anchor drivers 36, eachdriver being coupled to a respective anchor 32. Each driver 36 can beadvanced within channel 18 in order to advance and implant anchor 32 intissue. Following implantation of anchor 32, anchor 32 is decoupled fromdriver 36, as described herein, and driver 36 is removed from withinchannel 18. Subsequently, a new driver 36 coupled to another anchor 32is then advanced within channel 18.

As will be described hereinbelow, a first anchor 32 is configured to bedeployed through the wall of the sleeve into cardiac tissue, when sleeve26 is positioned along the annulus of the valve. Following thedeployment of the first anchor, a distal portion of sleeve 26 is sliddistally off a portion of implant-decoupling channel 18. In order todecouple sleeve 26 distally from a portion of outer surface of channel18, (1) a proximal force is applied to channel 18, while (2)reference-force tube 19 is maintained in place in a manner in which adistal end of tube 19 provides a reference force to sleeve 26 in orderto facilitate freeing of a successive portion of sleeve 26 from aroundchannel 18. Channel 18 is then positioned at a successive locationwithin the lumen of sleeve 26 while either tube 19 and/or catheter 14 issteered toward a successive location along the annulus of the valve (aswill be described hereinbelow). Consequently, the successive portion ofsleeve 26 provides a free lumen for advancement of a successive anchor32 and deployment of the anchor through the wall of the sleeve at thesuccessive portion thereof. Such freeing of the successive portion ofsleeve 26 creates a distance between successive anchors deployed fromwithin the lumen of sleeve 26.

For some applications, sleeve 26 comprises a plurality of radiopaquemarkers 25, which are positioned along the sleeve at respectivelongitudinal sites. The markers can provide an indication in aradiographic image (such as a fluoroscopy image) of how much of thesleeve has been deployed at any given point during an implantationprocedure, in order to enable setting a desired distance between anchors32 along the sleeve. For some applications, the markers comprise aradiopaque ink.

Often, at least a portion (e.g., three, at least three, some, all, etc.)of the longitudinal sites of the radiopaque markers are longitudinallyspaced at a constant interval. The longitudinal distance between thedistal edges of adjacent markers, and/or the distance between theproximal edges of adjacent markers, can be set equal to the desireddistance between adjacent anchors. For example, the markers can comprisefirst, second, and third markers, which first and second markers areadjacent, and which second and third markers are adjacent, and thedistance between the proximal and/or distal edges of the first andsecond markers equal the corresponding distance between the proximaland/or distal edges of the second and third markers. For example, thedistance can be between 3 and 15 mm, such as 6 mm, and the longitudinallength of each marker can be between 0.1 and 14 mm, such as 2 mm. (If,for example, the distance were 6 mm and the length were 2 mm, thelongitudinal gaps between adjacent markers would have lengths of 4 mm.)

Each anchor 32 can be coupled to deployment element 38 of anchor driver36. Anchor driver 36 comprises an elongate tube having at least aflexible distal end portion. The elongate tube of driver 36 extendswithin a lumen of channel 18, through system 10 toward a proximal end ofa proximal handle portion 101 of system 10. The tube of anchor driver 36provides a lumen for slidable advancement therethrough of an elongaterod 130. Rod 130 facilitates the locking and unlocking of anchor 32 todeployment element 38, as is described hereinbelow. As shown in SectionE-E of FIG. 2, a proximal end of rod 130 is coupled to a component of ananchor-release mechanism 28 at a proximal end of system 10. Mechanism 28comprises a housing 135 and a finger-engager 131 that is coupled to theproximal end of rod 130. Finger-engager 131 is coupled to a housing 135via a spring 133 (section E-E of FIG. 2). A proximal end of the tube ofanchor driver 36 is coupled to housing 135. As is described hereinbelow,the user (e.g., a physician, health care professional, etc.) releasesanchor 32 from deployment element 38 when finger-engager 131 is pulledproximally, thereby pulling rod 130 proximally.

For some applications, anchor driver 36 (e.g., rotation and/orproximal-distal movement thereof, and/or release of anchor 32) iselectronically controllable, such as by using an extracorporealcontroller and/or electric motor coupled to a proximal end of the anchordriver and/or housing 135.

Proximal handle portion 101 can be supported by a stand having supportlegs 91 and a handle-sliding track 90. Handle portion 101 comprises anouter-catheter handle 22, a guide-catheter handle 24, animplant-manipulating handle 126, and anchor-release mechanism 28. Handle22 is coupled to a proximal end of outer catheter 12. Handle 24 iscoupled to a proximal portion of guide catheter 14. Handle 126 iscoupled to a proximal portion of reference-force tube 19, and linearmovement of handle 126 with respect to handle 24 moves reference-forcetube 19 (and thereby typically structure 222) through catheter 14. Asdescribed hereinabove, housing 135 of anchor-release mechanism 28 iscoupled to a proximal portion of the tube of anchor driver 36. Therelative positioning of each of the concentrically-disposed componentsof system 10 is shown in the exploded view and sections A-A, B-B, C-C,and D-D of FIG. 2.

The stand supporting proximal handle portion 101 can be moved distallyand proximally to control a position of the entire multi-componentsystem 10, particularly so as to adjust a distance of distal end 102 ofcatheter 12 from the interatrial septum. Handle 22 comprises a steeringknob 210 that is coupled to pull wires 29 a and 29 b disposed withinrespective secondary lumens in the wall of outer catheter 12. Rotationof knob 210 adjusts a degree of tension of wires 29 a and 29 b which, inturn, apply a force to pull ring 11 at the distal end portion of outercatheter 12. Such force steers the distal end portion of catheter 12within the atrium of the heart of the patient in a manner in which thedistal end portion of catheter 12 is steered in a first plane that isparallel with the plane of the annulus of the valve (e.g., in adirection from the interatrial septum toward surrounding walls of theatrium). For some applications, the distal end portion of catheter 12can be pre-shaped so as to point downward toward the valve. For otherapplications, the distal end portion of catheter 12 can be pulled toassume an orientation in which the distal end portion points downwardtoward the valve. For some applications, the distal end portion ofcatheter 12 is not made to point downward toward the valve.

Handle 24 can be coupled to track 90 via a first mount 92. Mount 92 canbe slidable proximally and distally along track 90 in order to controlan axial position of guide catheter 14 with respect to outer catheter12. Mount 92 can be slidable via a control knob 216. For example,control knob 216 of mount 92 can control the proximal and distal axialmovement of the distal steerable portion of guide catheter 14 withrespect to distal end 102 of outer catheter 12. Handle 24 can comprise asteering knob 214 that is coupled to pull wires 31 a and 31 b disposedwithin respective secondary lumens in the wall of guide catheter 14.Rotation of knob 214 adjusts a degree of tension of wires 31 a and 31 bwhich, in turn, apply a force to pull ring 13 at the distal end portionof guide catheter 14. Such force steers the distal end portion ofcatheter 14 in a second plane within the atrium of the heart of thepatient downward and toward the annulus of the cardiac valve. Asdescribed hereinbelow, the distal end portion of guide catheter 14 canbe steered in the second plane that is substantially perpendicular withrespect to the first plane in which the distal end portion of outercatheter 12 is steered.

The combined steering of the respective distal end portions of catheters12 and 14 directs sleeve 26 down toward the annulus (e.g., via thesteering of the distal end portion of catheter 14) and along theperimeter of annulus (e.g., from the posterior section of the valve tothe anterior section of the valve, and vice versa), via the steering ofthe distal end portion of catheter 12.

For some applications, handle 22 can be tilted by the user (e.g., anoperating physician, etc.), in order to further adjust a position of thedistal end of catheter 12.

For some applications, handle 22 comprises an indicator that indicates adegree of steering (e.g., bending) of the distal end portion of catheter12 that has been produced using knob 210. For some applications, handle24 comprises an indicator that indicates a degree of steering (e.g.,bending) of the distal end portion of catheter 12 that has been producedusing knob 214.

As described herein, first and second couplings 152 and 154 of outercatheter 12 and guide catheter 14, respectively (e.g., slit 52 andengager 54, respectively), provide a controlled steerable system inwhich, during the steering and bending of the distal end portion ofguide catheter 14, the distal end portion of outer catheter 12 ismaintained in its steered configuration, or in its spatial orientation,without substantially affecting the steering or the bending of thedistal end portion of guide catheter 14. Thus, first and secondcouplings 152 and 154, respectively, minimize the effect of the distalend portion of outer catheter 12 on the steering and bending of catheter14. That is, first and second couplings 152 and 154 of outer catheter 12and guide catheter 14, respectively, collectively define arelative-spatial-orientation-controlling device which rotationally locksthe relative spatial orientation of the steerable distal end portion andthe bending section of outer catheter 12 with respect to the steerabledistal end portion and the bending section of guide catheter 14.

Contracting member 226 exits from the lumen in the wall of guidecatheter 14 at a portion of handle portion 101 that is between handles22 and 24.

Handle 126 can be coupled to track 90 via a second mount 93. Mount 93can be slidable proximally and distally along a track, in order tocontrol an axial position of reference-force tube 19 and at least aproximal portion of sleeve 26 with respect to guide catheter 14. Mount93 can be slidable via a control knob. For example, the control knob ofmount 93 can control the proximal and distal axial movement of the tube19 and at least the proximal portion of sleeve 26 with respect to distalend 104 of guide catheter 14. Taken together with the steering of thedistal end portion of guide catheter 14, such movement of tube 19 and atleast the proximal portion sleeve 26 moves the proximal portion ofsleeve 26 toward a desired portion of tissue of the annulus of the valveduring deployment of anchors 32 from within the lumen of sleeve 26, asis described hereinbelow.

As is described hereinabove, in order to decouple sleeve 26 from aportion of an outer surface of channel 18, (₁) channel 18 can be pulledproximally, while (2) reference-force tube 19 is maintained in place. Aproximal end of channel 18 can be coupled to a knob 94 which adjusts anaxial position of channel 18 proximally and distally with respect toreference-force tube 19 and sleeve 26.

Handle portion 101 can comprise a release-decision-facilitation member127, such as a latch or button, that automatically engages when a givenlength of sleeve 26 has advanced off channel 18 (e.g., when channel 18is at a given position with respect to tube 19); often just beforesleeve 26 becomes completely decoupled from channel 18. Engagement ofmember 127 inhibits proximal movement of channel 18 with respect to tube19, thereby reducing a likelihood of (e.g., preventing) inadvertentrelease of sleeve 26. In order to release sleeve 26 (e.g., to decouplechannel 18 from the sleeve), the user (e.g., an operating physician)must disengage member 127, such as by pushing the button, beforecontinuing to withdraw channel 18 proximally. When engaged, member 127can also inhibit distal movement of channel 18 with respect to tube 19.

Handle portion 101 (comprising handles 22, 24, and 126 andanchor-release mechanism 28) can have a length L1 of between 65 and 85cm, e.g., 76 cm. As shown, a majority of the body portion ofouter-catheter handle 22 can be disposed at a non-zero angle withrespect to a longitudinal axis 7 of the multiple components of system10. The steering mechanism provided by handle 22 in order to steer thedistal end portion of catheter 12 is disposed within the portion ofhandle 22 that is disposed at the non-zero angle with respect to axis 7.Handle 22 comprises an in-line tubular portion 21 which islongitudinally disposed in-line along axis 7 and coaxially with respectto handles 24 and 126 and release mechanism 28. Tubular portion 21 isshaped so as to define a lumen for inserting guide catheter 14therethrough and subsequently into the lumen of outer catheter 12.Tubular portion 21 has a length L24 of between 7 and 11 cm, e.g., 7 cm.Such spatial orientation of the majority of handle 22 at an angle withrespect to axis 7 reduces an overall functional length of handle portion101.

Reference is now made to FIGS. 3A-I, which are schematic illustrationsof an example of a procedure for implanting an annuloplasty structure222 (e.g., an annuloplasty ring structure, a closed annuloplastystructure, a closed annuloplasty ring structure, an open annuloplastystructure, a partial annuloplasty ring structure, etc.) to repair amitral valve 230. This procedure is one example of a procedure that canbe performed using system 10.

Annuloplasty structure or annuloplasty ring structure 222 can be used torepair a dilated valve annulus of an atrioventricular valve, such asmitral valve 230. For some applications, the annuloplasty structure isconfigured to be placed only partially around the valve annulus (e.g.,to assume a C-shape), and, once anchored or otherwise secured in place,to be contracted so as to circumferentially tighten the valve annulus.For some applications, the annuloplasty structure is configured to beplaced fully around the valve annulus (e.g., to assume a closed shape,such as a circle, oval, D-shape, etc.), and, once secured in place, tobe contracted so as to circumferentially tighten the valve annulus. Theannuloplasty structure can comprise a flexible sleeve 26. Theannuloplasty structure can also comprise and/or be used with anattachment means (e.g., anchor(s), fastener(s), clamp(s), suture(s),clip(s), etc.), such as a plurality of anchors 32. Anchor deploymentmanipulator 61 is advanced into a lumen of sleeve 26, and, from withinthe lumen, deploys the anchors through a wall of the sleeve and intocardiac tissue, thereby anchoring the sleeve around a portion of thevalve annulus. For some applications, annuloplasty structure orannuloplasty ring structure 222 is implemented using techniquesdescribed in U.S. application Ser. No. 12/437,103, filed May 7, 2009which issued as U.S. Pat. No. 8,715,342, and/or U.S. application Ser.No. 12/689,635, filed Jan. 19, 2010 which issued as U.S. Pat. No.8,545,553, both of which are assigned to the assignee of the presentapplication and are incorporated herein by reference.

As shown in FIG. 3A, the procedure can begin by advancing a semi-rigidguidewire 202 into a right atrium 220 of the patient. The procedure canbe performed with the aid of imaging, such as fluoroscopy,transesophageal echo, and/or echocardiography.

As show in FIG. 3B, guidewire 202 provides a guide for the subsequentadvancement of outer catheter 12 therealong and into the right atrium.Once a distal portion of catheter 12 has entered the right atrium,guidewire 202 is retracted from the patient's body. Catheter 12 cancomprise a 14-24 F sheath, although any size may be selected asappropriate for a given patient. Catheter 12 is advanced throughvasculature into the right atrium using a suitable point of origindetermined for a given patient. For example:

-   -   catheter 12 can be introduced into the femoral vein of the        patient, through an inferior vena cava 223, into right atrium        220, and into a left atrium 224 transseptally, for example,        through the fossa ovalis;    -   catheter 12 can be introduced into the basilic vein, through the        subclavian vein to the superior vena cava, into right atrium        220, and into left atrium 224 transseptally, for example,        through the fossa ovalis; or    -   catheter 12 can be introduced into the external jugular vein,        through the subclavian vein to the superior vena cava, into        right atrium 220, and into left atrium 224 transseptally, for        example, through the fossa ovalis.

For some applications, catheter 12 is advanced through inferior venacava 223 of the patient (as shown) and into right atrium 220 using asuitable point of origin for a given patient.

Catheter 12 can be advanced distally until the sheath reaches theinteratrial septum, and guidewire 202 is withdrawn, as shown in FIG. 3C.

As shown in FIG. 3D, a resilient needle 206 and a dilator (not shown)are advanced through catheter 12 and into the heart. In order to advancecatheter 12 transseptally into left atrium 224, the dilator is advancedto the septum, and needle 206 is pushed from within the dilator and isallowed to puncture the septum to create an opening that facilitatespassage of the dilator and subsequently catheter 12 therethrough andinto left atrium 224. The dilator is passed through the hole in theseptum created by the needle. The dilator can be shaped to define ahollow shaft for passage along needle 206, and the hollow shaft isshaped to define a tapered distal end. This tapered distal end is firstadvanced through the hole created by needle 206. The hole is enlargedwhen the gradually increasing diameter of the distal end of the dilatoris pushed through the hole in the septum. For some applications, adistal end 102 of catheter 12 is tapered so as to facilitate passage ofthe distal portion of catheter 12 through the opening in the septum.

The advancement of catheter 12 through the septum and into the leftatrium can be followed by the extraction of the dilator and needle 206from within catheter 12, as shown in FIG. 3E. Once the distal portion ofcatheter 12 is disposed within atrium 224, the steerable distal endportion of catheter 12 (e.g., a bending section 1203 of catheter 12) canbe steered in a first plane that is parallel to a plane of the annulusof mitral valve 230. Such steering moves the distal end portion ofcatheter 12 in a direction from the interatrial septum towardsurrounding walls of the atrium, as indicated by the arrow in atrium224. As described hereinabove, steering of the distal portion ofcatheter 12 can be performed via steering knob 210 of handle 22 inhandle portion 101 (in FIGS. 1 and 2).

As shown in FIG. 3F, annuloplasty structure or annuloplasty ringstructure 222 (not shown for clarity of illustration, with anchordeployment manipulator 61 therein) is advanced through guide catheter14, which is in turn, advanced through catheter 12 into left atrium 224.As shown in FIG. 3F, an exposed distal end portion 114 (e.g., a bendingsection 1403) of catheter 14 extends beyond distal end 102 of catheter12. Exposed distal end portion 114 is then (1) steered toward theannulus of valve 230 along a plane that is perpendicular with respect tothe steering plane of catheter 12 and that is perpendicular with respectto valve 230, and is (2) bent, via bending section 1403 toward valve230. As described hereinabove, steering of the distal portion ofcatheter 14 is performed via steering knob 214 of handle 24 in handleportion 101 (in FIGS. 1 and 2).

As shown in FIG. 3G, a distal end 251 of sleeve 26 is positioned in avicinity of a left fibrous trigone 242 of an annulus 240 of mitral valve230. (It is noted that for clarity of illustration, distal end 251 ofsleeve 26 is shown schematically in the cross-sectional view of theheart, although left trigone 242 is in reality not located in the showncross-sectional plane, but rather out of the page closer to the viewer.)Alternatively, the distal end of sleeve 26 is positioned in a vicinityof a right fibrous trigone 244 of the mitral valve (configuration notshown). Further alternatively, the distal end of the sleeve is notpositioned in the vicinity of either of the trigones, but is insteadpositioned elsewhere in a vicinity of the mitral valve, such as in avicinity of the anterior or posterior commissure. Once positioned at thedesired site near the selected trigone, deployment manipulator 61deploys a first anchor 32 through the wall of sleeve 26 (by penetratingthe wall of the sleeve in a direction in a direction parallel to acentral longitudinal axis of deployment manipulator 61, or anchor driver36, through the distal end of channel 18, and/or parallel to centrallongitudinal axis of tissue-engaging element 60 of anchor 32) intocardiac tissue near the trigone. Following the deployment of anchor 32in the cardiac tissue, deployment element 38 is decoupled from anchor 32by moving rod 130 proximally.

Anchors 32 can be deployed from a distal end of manipulator 61 while thedistal end is positioned such that a central longitudinal axis throughthe distal end of manipulator 61 forms an angle with a surface of thecardiac tissue of between about 20 and 90 degrees, e.g., between 45 and90 degrees, such as between about 75 and 90 degrees, such as about 90degrees. Anchors 32 can be deployed from the distal end of manipulator61 into the cardiac tissue in a direction parallel to the centrallongitudinal axis through the distal end of manipulator 61. Such anangle can be provided and/or maintained by channel 18 being more rigidthan sleeve 26. Distal end 17 (shown in FIG. 2) of channel 18 can bebrought close to the surface of the cardiac tissue (and the wall ofsleeve 26 that is disposed against the surface of the cardiac tissue),such that little of each anchor 32 is exposed from channel 18 beforepenetrating the sleeve and the tissue. For example, distal end 17 ofchannel 18 can be placed (e.g., pushed) against the wall of the sleeve,sandwiching the sleeve against the cardiac tissue.

For some applications, this placement of distal end 17 of channel 18against the cardiac tissue (via the wall of the sleeve), stabilizes thedistal end during deployment and anchoring of each anchor 32, andthereby facilitates anchoring. For some applications, pushing of distalend 17 against the cardiac tissue (via the wall of the sleeve)temporarily deforms the cardiac tissue at the site of contact. Thisdeformation can facilitate identification of the site of contact usingimaging techniques (e.g., by identifying a deformation in the borderbetween cardiac tissue and blood), and thereby can facilitate correctpositioning of the anchor.

For some applications, anchors 32 can be deployed from a lateral portionof manipulator 61.

Reference is now made to FIGS. 3G and 2. Following the deployment of thefirst anchor, a distal portion of sleeve 26 can be decoupled from aportion of implant-decoupling channel 18. In order to decouple theportion of sleeve 26 from outer surface of channel 18, (1) channel 18can be pulled proximally, while (2) reference-force tube 19 ismaintained in place in a manner in which a distal end of tube 19provides a reference force to sleeve 26 in order to facilitateretraction freeing of a successive portion of sleeve 26 from aroundchannel 18. In order to decouple sleeve 26 from the outer surface ofchannel 18, (1) channel 18 can be pulled proximally, while (2)reference-force tube 19 is maintained in place. An indicator (such asindicator 2120 described in PCT patent application PCT/IL2012/050451 toSheps et al., which published as WO/2013/069019, which is incorporatedherein by reference) on handle 126 provides an indication of how muchchannel 18 is withdrawn from within sleeve 26 (i.e., how much thedelivery tool is decoupled from sleeve 26, and how much the sleeve hasadvanced off channel 18 and against tissue). A proximal end of channel18 is coupled to a knob 94 (FIG. 2) which adjusts an axial position ofchannel 18 proximally and distally with respect to reference-force tube19 and sleeve 26. As shown in FIG. 3H, deployment manipulator 61 isrepositioned along annulus 240 to another site selected for deploymentof a second anchor 32. Reference is now made to FIGS. 1 and 3H. Suchrepositioning of manipulator 61 is accomplished by:

-   -   (1) the steering of the distal end portion of catheter 12 (e.g.,        by steering knob 210 of handle 22) in the first plane that is        parallel with respect to annulus 240 of valve 230 to a desired        spatial orientation and in a manner which bends a bending        section 1203 of catheter 12,    -   (2) the steering of the distal end portion of portion of        catheter 14 (e.g., by steering knob 214 of handle 24) in the        second plane that is perpendicular with respect to annulus 240        of valve 230 to a desired spatial orientation, and in a manner        which bends bending section 1405 of catheter 14 (specifically        bending section 1403),    -   (3) by axially moving catheter 14 with respect to catheter 12        via knob 216,    -   (4) by axially moving the stand supporting handles 22 and 24 to        move both catheters 12 and 14,    -   (5) by moving tube 19 and sleeve 26 axially by sliding mount 93        along track 90 via knob 95, and/or    -   (6) by moving channel 18 relative to tube 19 by actuating knob        94.

Often, the first anchor is deployed most distally in the sleeve(generally at or within a few millimeters of the distal tip of thesleeve), and each subsequent anchor is deployed more proximally, suchthat the sleeve is gradually decoupled from channel 18 of deploymentmanipulator 61 in a distal direction during the anchoring procedure(i.e., channel 18 is withdrawn from within sleeve 26, and handle 126 ismoved distally so as to retract the tool to make the successive proximalportion sleeve 26 ready for implantation of a subsequent anchor). Thealready-deployed first anchor 32 holds the anchored end of sleeve 26 inplace, so that the sleeve is drawn from the site of the first anchortowards the site of the second anchor. As sleeve 26 is decoupled fromchannel 18, deployment manipulator 61 can be moved generally laterallyalong the cardiac tissue, as shown in FIG. 3H. Deployment manipulator 61deploys the second anchor through the wall of sleeve 26 into cardiactissue at the second site. Depending on the tension applied between thefirst and second anchor sites, the portion of sleeve 26 therebetween canremain tubular in shape, or can become flattened, which may help reduceany interference of the ring with blood flow.

As shown in FIG. 3I, deployment manipulator 61 can be repositioned alongthe annulus to additional sites, at which respective anchors aredeployed, until the last anchor is deployed in a vicinity of rightfibrous trigone 244 (or left fibrous trigone 242 if the anchoring beganat the right trigone). Optionally, the last anchor is not deployed inthe vicinity of a trigone, but is instead deployed elsewhere in avicinity of the mitral valve, such as in a vicinity of the anterior orposterior commissure. Then, system 10 is removed, leaving behind implantstructure 222 and contracting member 226. As is described hereinbelow, acontracting-member-uptake tool is then threaded over and advanced alongcontracting member 226 and toward structure 222, and is used to contractstructure 222 by adjusting a degree of tension of contracting member 226(not shown in FIG. 3I, but (i) advancing of contracting-member-uptaketool over contracting member 226 is described with reference to FIGS.4A-5D, mutatis mutandis, and (ii) applying tension to member 226 isdescribed hereinbelow with reference to FIGS. 6A-B).

Once the desired level of adjustment of structure 222 is achieved (e.g.,by monitoring the extent of regurgitation of the valve underechocardiographic and/or fluoroscopic guidance), thecontracting-member-uptake tool (1) locks contracting member 226 so as tomaintain a degree of tension of member 226 in order to maintainstructure 222 in a contracted state, and (2) severs any excess portionof contracting member 226 which is then removed from the heart. For someapplications, a distal portion of guide member 86 may be left within theheart of the patient and the proximal end can be accessible outside thebody, e.g., using a port. For such applications, adjusting mechanism 40can be accessed at a later stage following initial implantation andadjustment of ring structure 222.

For some applications, a re-access wire 288 can be provided, coupled toa proximal portion of the implant (e.g., a portion of the implant thatis deployed last), such as to a last anchor 32 (as shown in FIG. 3I) orsleeve 26, such that, upon anchoring, the wire extends proximally, e.g.,out of the body of the subject, such as via catheter 14 and/or catheter12. Should it be determined, after implantation (e.g., and afteradjustment) of annuloplasty structure 222, that one or more anchors 32require adjustment or retrieval, re-access wire 288 facilitates guidanceof an anchor-manipulation tool to annuloplasty structure 222 and/or intothe lumen thereof. For example, such an anchor-manipulation tool cancomprise an anchor-manipulation tool described in a PCT patentapplication PCT/IL2013/050861 to Herman et al, titled “Percutaneoustissue anchor techniques”, filed on Oct. 23, 2013, and incorporatedherein by reference. Systems, apparatuses, and techniques described inthe present patent application can be used in combination with systems,apparatuses, and techniques described in said PCT patent applicationPCT/IL2013/050861.

As shown, sleeve 26 of ring structure 222 comprises a plurality ofradiopaque markers 25, which are positioned along the sleeve atrespective longitudinal sites to indicate anchor-designated targetareas. The markers can provide an indication in a radiographic image(such as a fluoroscopy image) of how much of sleeve 26 has been deployedat any given point during an implantation procedure, in order to enablesetting a desired distance between anchors 32 along the sleeve 26.

For some applications, and as shown in FIG. 3I, anchors 32 are deployedat longitudinal sites of sleeve 26 at which radiopaque markers 25 aredisposed (e.g., the anchors are driven through a radiopaque ink of theradiopaque markers). Alternatively, anchors 32 can be deployed atlongitudinal sites of sleeve 26 between markers 25. For example, whendispensing sleeve 26 from channel 18 (i.e., when advancing sleeve 26with respect to channel 18 and/or withdrawing channel 18 from sleeve26), the appearance of a marker 25 at the distal end of channel 18(e.g., the marker 25 becoming aligned with marker 1018 of channel 18)can indicate that a correct length of sleeve 26 has been dispensed.Subsequent limited movement of the channel with respect to the sleevemay occur. For example, when channel 18 is placed against the annulus,the channel may tension the portion of sleeve 26 between thepreviously-deployed anchor and the distal end of the channel, such thatwhen the anchor is deployed, it passes through the sleeve slightlyproximally to the marker 25 (e.g., 1-2 mm proximally to the marker).

Alternatively, annuloplasty structure 222 is implanted by right or leftthoracotomy, mutatis mutandis.

For some applications, following implantation of sleeve 26 along theannulus, an excess portion of sleeve 26 may be present at the proximalportion of sleeve. In such applications, following removal ofmanipulator 61, a cutting tool (not shown) can be advanced withinchannel 18 and into the lumen of the excess portions of sleeve 26 (e.g.,from within sleeve 26) in order to cut the sleeve proximal to theproximal-most-deployed anchor 32.

Reference is now made to FIGS. 4A-B, which are schematic illustrationsof an example system 10 comprising an example contracting-member-uptaketool 300 which is configured to contract contracting member 226 andsever any excess portions of contracting member 226. Tool 300 comprisesa handle portion 320 and an elongate sheath 310 coupled thereto. Sheath310 encases a primary tube 330 and a secondary tube 340 disposedalongside primary tube 330. Both primary tube 330 and secondary tube 340are coupled to handle portion 320 at respective proximal ends of tubes330 and 340. Secondary tube 340 has a secondary-tube-lumen configuredfor passage therethrough of contracting member 226. Tool 300 defines alongitudinal axis 301.

For some applications, sheath 310 is shaped so as to define a lumen in awall of sheath 310. For such applications, tool 300 does not comprisesecondary tube 340, but rather, the lumen in the wall of sheath 310functions as secondary tube 340 and the primary lumen defined by thewall of sheath 310 functions as primary tube 330.

Sheath 310, primary tube 330, and secondary tube 340 can be flexiblesuch that sheath 310, primary tube 330, and secondary tube 340 areconfigured for passage through vasculature of the patient during atransvascular, transcatheter procedure. However, similar features can beused for surgical procedures. For some applications, sheath 310, primarytube 330, and secondary tube 340 comprise silicone. For someapplications, sheath 310, primary tube 330, and secondary tube 340comprise polyurethane.

Tool 300 can comprise a contracting-member-snare 350 comprising a distalsnare portion 352 and an elongate flexible body portion 354 coupled todistal snare portion 352. Distal snare portion 352 is configured toensnare a portion of contracting member 226 as will be describedhereinbelow and is sized to pass through the secondary-tube lumen ofsecondary tube 340 in order to pull contracting member 226 through alength of secondary tube 340.

Distal snare portion 352 can define a looped portion, as shown. For someapplications, distal snare portion 352 is shaped so as to define a hook.

Tool 300 can comprise a distal end portion 333 having a distal tip 331which defines a distal end of tool 300. Primary tube 330 terminates atdistal end portion 333. Distal end portion 333 comprises a housing 332which is shaped so as to hold and be removably coupled to acontracting-member-fastener 360. Contracting-member-fastener 360comprises a clamping structure that can be biased toward assuming aclosed state or closed position, and in the closed state/position, theclamping structure can be configured to clamp onto the contractingmember 226 passed therethrough (not shown). The clamping structure canalso be configured such that it can be flexed to an open state throughwhich contracting member 226 (not shown) can move.

Tool 300 can comprise a fastener-ejector 335 movable within distal endportion 333 of contracting-member-uptake tool 300. Movement offastener-ejector 335 converts contracting-member-fastener 360 (orclamping structure thereof) from its open state to its closed state toclamp onto contracting member 226 passed therethrough, as will bedescribed hereinbelow. Tool 300 comprises a stop 362 removably coupledto contracting-member-fastener 360 and configured to maintaincontracting-member-fastener 360 in the open state, as shown in SectionA-A of FIG. 4A. Stop 362 comprises one or more, e.g., two, prongs 337which maintain fastener 360 in the open state. Ejector 335 is coupled tostop 362 and moves stop 362 that is removably coupled to fastener 360 inorder to convert fastener 360 from the open state to a closed state, asis described hereinbelow.

FIG. 4B shows handle portion 320 of tool 300 with a casing removed inorder to view the inside of handle portion 320. Handle portion 320comprises a contracting-member-uptake device 322 configured to uptakesuccessive portions of contracting member 226 (not shown), as isdescribed hereinbelow. Contracting-member-uptake device 322 isactuatable to increase tension of the contracting member, as isdescribed hereinbelow. Tension of contracting member 226 is measured bya tension meter 324 of handle portion 320.

Contracting-member-uptake device 322 can optionally comprise a wheel,which can have two opposing wedged portions 325 which together define agroove 326 configured to couple contracting member 226 to the wheel ofdevice 322. Wedged portions 325 can be shaped so as to receive anyportion of contracting member 226, e.g., a proximal end of member 226and/or a middle portion of member 226. For some applications, opposingwedged portions 325 are configured to grip contracting member 226. Asshown, the wheel of device 322 can have a numerical indicator toindicate the number of turns of the wheel.

As shown, handle portion 320 is coupled to respective proximal portionsof primary tube 330 and secondary tube 340.

Handle portion 320 can be shaped so as to define a lumen 328 for passagetherethrough of snare 350 from within the lumen of secondary tube 340.Snare 350 passes through lumen 328 and beyond groove 326 ofcontracting-member-uptake device 322. Often, but not necessarily, device322 does not uptake snare 350 but rather, snare 350 passes throughgroove 326. As is described hereinbelow, pulling on snare 350 pulls oncontracting member 226 coupled thereto such that contracting member 226is pulled through secondary tube 340, through lumen 328 and ultimatelytoward contracting-member-uptake device 322. Once the proximal end ofcontracting member 226 (or a portion in a vicinity of the proximal endof member 226) is pulled through tube 340 and through lumen 328,contracting member 226 is coupled to contracting-member-uptake device322 by being fed into groove 326. Contracting-member-uptake device 322is then actuated in order to apply tension to contracting member 226,and thereby to annuloplasty structure 222 implanted along the annulus.With each rotation of the wheel of device 322, successive portions ofcontracting member 226 are wound within groove 326 of device 322.

FIGS. 5A-D are schematic illustrations of an examplecontracting-member-uptake tool 300 useable to uptake contracting member226. At this stage, annuloplasty structure or annuloplasty ringstructure 222 has been implanted along annulus 240, as describedhereinabove with reference to FIGS. 3A-I. Once structure 222 has beenimplanted along the annulus, contracting member 226 extends away fromstructure 222 and through vasculature of the patient such that aproximal end portion of member 226 is disposed outside the body of thepatient.

Contracting member 226 can exit sleeve 26 of structure 222 at anysuitable location along structure 222. For example, contracting member226 can exit sleeve 26 of structure 222 at a portion of structure 222 ina vicinity of a left fibrous trigone of the valve, as shown. For someapplications, contracting member 226 exits sleeve 26 of structure 222 ata portion of structure 222 in a vicinity of a right fibrous trigone ofthe valve. For some applications, contracting member 226 exits sleeve 26of structure 222 at a middle portion of structure 222.

As shown, structure 222 comprises sleeve 26 which defines the primarybody portion of structure 222. Contracting member 226 has a firstportion 420 extending along a longitudinal length of the primary bodyportion of annuloplasty structure 222. The first portion 420 can extendalong the longitudinal length of structure 222 when structure 222 is ina linear state as well as in a curved state, as shown in FIG. 5A.Contracting member 226 also defines a second portion 422 extending awayfrom the primary body portion of annuloplasty structure 222.

In FIG. 5A, the user (e.g., an operating physician, etc.) can hold adistal end of tool 300 in one hand and a proximal end portion ofcontracting member 226 in another hand. The user or physician threadsthe proximal end portion of contracting member 226 through distal snareportion 352 of contracting-member-snare 350.

FIG. 5B shows tool 300 in a state in which distal snare portion 352ensnares contracting member 226. For some applications, distal snareportion 352 is shaped so as to increase the coupling between snare 350and contracting member 226. For example, for some applications, distalsnare portion 352 is corrugated to increase friction between snareportion 352 and contracting member 226. For some applications, distalsnare portion 352 can comprise a coiled section to increase frictionbetween snare portion 352 and contracting member 226. For someapplications, snare 350 comprises a metal wire. For some applications,snare 350 comprises a metal wire comprising stainless steel. Snare 350(including distal snare portion 352) can have a variety of sizes, forexample, a diameter of 0.15-0.5 mm or 0.15-0.35 mm.

Reference is now made to FIGS. 4A and 5B. As shown in Section A-A ofFIG. 4A, contracting-member-snare 350 passes through aligned ports 339and 341 in distal end portion 333 of tool 300.

Snare 350 can be pulled proximally, e.g., by the user or physicianholding the proximal exposed end portions 351 of snare 350 proximallyaway from tool 300. Pulling on snare 350 proximally, as shown in FIG.5C, pulls distal snare portion 352 and contracting member 226 loopedtherethrough through distal tip 331 of tool 300, through the fastenerdisposed within distal end portion 333 of tool 300, through alignedports 339 and 341 in distal end portion 333 of tool 300, andsubsequently, through the lumen of secondary tube 340.

Snare 350 is pulled until distal snare portion 352 enters the lumen ofsecondary tube 340. As a result, the looped portion of distal snareportion 352 is compressed and collapses around contracting member 226looped therethrough, in order to maintain coupling between snare portion352 and contracting member 226 as elongate flexible body portion 354(shown in FIG. 5B) is pulled through the lumen of secondary tube 340. Asthe looped portion of snare portion 352 collapses within the lumen ofsecondary tube 340, the portion of contracting member 226 ensnared bysnare portion 352 bends, and coupling between contracting member 226 andsnare portion 352 is strengthened. This strengthening is also broughtabout as a result of the relatively small diameter of secondary tube 340of 0.5-1.0 mm.

In FIG. 5D, snare 350 is pulled entirely through secondary tube 340,through lumen 328 of handle portion 320 and beyond groove 326 ofcontracting-member-uptake device 322 in order to pull contracting member226 along this path. All the while, sheath 310 of tool 300 is advancedthrough vasculature and toward annuloplasty structure 222 implantedalong annulus 240 of the valve. Once distal snare portion 352 and theportion of contracting member 226 coupled thereto exit lumen 328 ofhandle portion 320, the portion of contracting member 226 is coupled tocontracting-member-uptake device 322 by being positioned within groove326. For some applications, the proximal end portion of contractingmember 226 is fed within groove 326. For some applications, a middleportion of contracting member 226 (e.g., a portion in a vicinity of theproximal end of contracting member 226) is fed within groove 326.Contracting member 226 is then tightened by actuating, e.g., rotating,contracting-member-uptake device 322 such that successive portions ofcontracting member 226 are wound within contracting-member-uptake device322 and contracting-member-uptake device 322 uptakes the successiveportions.

Once snare 350 has been pulled through tool 300, snare 350 can bediscarded.

Reference is now made to FIGS. 6A-B, which are schematic illustrationsof an example tool 300 used to pull on contracting member 226 in orderto contract contracting member 226 and thereby annuloplasty structure orannuloplasty ring structure 222 coupled thereto.Contracting-member-uptake device 322 is rotated in order to facilitatethe uptake of successive portions of contracting member 226.

As shown in FIG. 6A, prior to rotating contracting-member-uptake device322, tension meter 324 of handle portion 320 reads a tension ofcontracting member 226 at zero or close to zero. Similarly, sleeve 26 ofannuloplasty structure 222 coupled to annulus 240 is in a relaxed,non-tense state. At this point, tool 300 has been sufficiently advancedthrough vasculature of the patient such that distal tip 331 is inproximity to structure 222 disposed along the annulus, while a proximalportion of contracting member 226 is disposed outside the body of thepatient.

In FIG. 6B, contracting-member-uptake device 322, is rotated to contractand apply tension to contracting member 226. Tension meter 324 of handleportion 320 reads a tension of contracting member 226 between 4 and 5.Similarly, sleeve 26 of annuloplasty structure 222 coupled to annulus240 is in a tense, contracted state. As shown in FIG. 6B, contractingmember 226 is in a tense state with respect to tool 300.

Reference is now made to FIGS. 7A-E, which are schematic illustrationsof an example tool 300 used to lock and secure annuloplasty structure222 in its contracted state and subsequently, sever excess portions ofcontracting member 226.

FIG. 7A shows annuloplasty structure or annuloplasty ring structure 222in a non-contracted state. Distal tip 331 of tool 300 can be broughtclose to structure 222. Contracting member 226 can be threaded alongsleeve 26 and out of a portion of sleeve 26 of structure 222. Asdescribed hereinabove, contracting member 226 can be threaded throughtool 300 in a manner in which member 226 passes through distal tip 331,through contracting-member-fastener 360 that can be held in the openstate, such as by prongs 337 of stop 362, through aligned ports 339 and341 in distal end portion 333 of tool 300, and through secondary tube340.

As shown in FIG. 7B, once distal tip 331 of tool 300 contacts sleeve 26of structure 222, tool 300 can be used to contract structure 222 by tool300 pulling on contracting member 226. During contraction of structure222, fastener 360 is not deployed.

In FIG. 7C, contracting member 226 has been pulled tight, andannuloplasty structure 222 has been contracted and in a tense,contracted state. Distal end portion 333 of tool 300 is then used toeject and deploy fastener 360 from within tool 300 in order to lockstructure 222 in the contracted state.

Reference is now made to FIGS. 6B and 7C. Once distal tip 331 contactssleeve 26, a trigger 321 (shown in FIG. 6B) at handle portion 320 oftool 300 is pulled partially, in order to facilitate ejecting anddeploying of contracting-member-fastener 360 from within housing 332 ofdistal end portion 333. As described hereinabove, fastener-ejector 335is movable within distal end portion 333 of contracting-member-uptaketool 300. Movement of fastener-ejector 335 convertscontracting-member-fastener 360 from its open state to its closed stateto clamp onto contracting member 226 passed therethrough.Fastener-ejector 335 is coupled to prongs 337 of stop 362 in a manner inwhich when ejector 335 is moved proximally within portion 333, stop 362is decoupled from contracting-member-fastener 360 as prongs 337 moveproximally away from contracting-member-fastener 360. Oncecontracting-member-fastener 360 is no longer held in the open state bystop 362, fastener 360 closes, as it tends to do, and clamps aroundcontracting member 226 passing therethrough.

A proximal portion of fastener-ejector 335 can be coupled to a distalend of a movement tube 343 which can be coupled at a proximal endthereof to trigger 321. Movement tube 343 is movable proximally inresponse movement of trigger 321, and consequently, fastener-ejector 335is moved proximally with respect to distal tip 331 of tool 300 and withrespect to fastener 360. As shown in FIG. 7B, fastener 360 has beenejected and deployed from within housing 332 of ejector 335.

In FIG. 7D, fastener-ejector 335 can be moved further proximally inresponse to the further pulling of trigger 321, in order to sever excessportions of contracting member 226. Tool 300 can be shaped so as todefine a cutting-facilitating edge 370 in distal end portion 333 of tool300. For some applications, cutting-facilitating edge 370 defines asharp edge. While contracting member 226 passes through aligned ports339 and 341 in distal end portion 333 of tool 300, as shown in FIGS.7A-C, contracting member 226 is in proximity with cutting-facilitatingedge 370. Movement of fastener-ejector 335 proximally brings acutting-facilitating edge 372 of ejector 335 againstcutting-facilitating edge 370 of tool 300, thus sandwiching a portion ofcontracting member 226 between edges 370 and 372, in order to sever andcut contracting member 226 extending through ports 339 and 341. For someapplications, cutting-facilitating edge 372 defines a sharp edge. FIG.7D shows contracting member 226 severed once cutting-facilitating edge372 of ejector 335 has been brought against cutting-facilitating edge370 of tool 300.

As shown in FIG. 7E, once contracting member 226 has been severed, tool300 is withdrawn proximally, bringing together with it the excessportion of contracting member 226.

Reference is now made to FIGS. 8A-D, which are schematic illustrationsof an example of a system 510 for contracting annulus 240 of the patientusing an annuloplasty structure 522 (e.g., an annuloplasty ringstructure, a closed annuloplasty structure, a closed annuloplasty ringstructure, an open annuloplasty structure, a partial annuloplasty ringstructure, etc.), which can comprise a housing 530. Housing 530 canhouse a contracting-member-fastener 360. Except for the differencesdescribed hereinbelow, annuloplasty structure 522 can be the same as orgenerally similar to annuloplasty structure 222, described hereinabovewith reference to FIGS. 1-7E and like reference numerals refer to likeparts.

Annuloplasty structure or annuloplasty ring structure 522 can comprisesleeve 26 which can define a primary body portion of structure 522.Structure 522 comprises contracting member 226 having a first portion526 extending along a longitudinal length of the primary body portion ofannuloplasty structure 522. The first portion 526 can extend along thelongitudinal length of structure 522 when structure 522 is in a linearstate as well as in a curved state, as shown in FIG. 8A. Contractingmember 226 also defines a second portion 524 extending away from theprimary body portion of annuloplasty structure 522.

Contracting member 226 can extend through housing 530 and through a stop570 (e.g., a holder) that is disposed within an opening ofcontracting-member-fastener 360. Stop 570 is shown as being cylindricalby way of illustration and not limitation. The outer surface of stop 570maintains fastener 360 in the open state. Stop 570 is shaped so as todefine a threaded portion 572 which enables coupling thereto of acontracting-member-uptake tool, as is described hereinbelow.

Annuloplasty structure or annuloplasty ring structure 522 is implantedas described hereinabove with reference to FIGS. 3A-I using the systemdescribed hereinabove with reference to FIGS. 1-3I.

Housing 530 can be coupled to sleeve 26 of structure 522 at any suitablelocation along structure 522. For example, housing 530 can be coupled tosleeve 26 of structure 522 at a portion of structure 522 in a vicinityof a left fibrous trigone of the valve, as shown. For some applications,housing 530 can be coupled to sleeve 26 of structure 522 at a portion ofstructure 522 in a vicinity of a right fibrous trigone of the valve. Forsome applications, housing 530 can be coupled to sleeve 26 of structure522 at a middle portion of structure 522. As shown, housing 530 can becoupled to a lateral surface of sleeve 26. In such applications, housing530 does not block them lumen of sleeve 26 of structure 522.

FIG. 8B shows a contracting-member-uptake tool 600 through whichcontracting member 226 has been threaded. Contracting member 226 can beensnared by tool 600 using a snare as described herein above with regardto snare 350 with reference to FIGS. 4A-5D. Tool 600 can be advancedalong contracting member 226 toward housing 530 of structure 522, in amanner similar to tool 300 advancing along contracting member 226, asdescribed hereinabove with reference to FIGS. 4A-5D.

Tool 600 can comprise a distal tip 631 and a distal end portion 633which is generally similar to distal end portion 533 of tool 300,described hereinabove with reference to FIGS. 4A-7E and like referencenumerals refer to like parts. Since annuloplasty structure 522 comprisescontracting-member-fastener 360 and stop 570 removably coupled tofastener 360, distal end portion 633 of tool 600 is unlike distal endportion 533 of tool 300 of FIGS. 4A-7E, remaining parts of tool 600correspond to the remaining parts of tool 300.

Once tool 600 is threaded along contracting member 226, contractingmember 226 extends from sleeve 26, through stop 570, through astop-coupler 672 of tool 600, through distal tip 631, and then throughaligned ports 339 and 341 of distal end portion 633 of tool 600.

Stop-coupler 672 of tool 600 screws into and engages threaded portion572 of stop 570 coupled to contracting-member-fastener 360 disposedwithin housing 530 of structure 522.

As described hereinabove with reference to FIGS. 6A-B, acontracting-member-uptake device of tool 600 (not shown, but similar tocontracting-member-uptake device 322 of tool 300) can be used tocontract contracting member 226. Once contracting member 226 iscontracted and structure 522 is contracted, as shown in FIG. 8C, tool600 removes stop 570 by pulling stop 570 proximally away from fastener360. Since fastener 360 tends to close, in the absence of stop 570,fastener 360 closes and clamps around contracting member 226 passingthrough fastener 360. In such a manner, structure 522 is locked byfastener 360 and the contracted state of structure 522 is maintained.

FIG. 8D shows contracting member 226 being severed proximal to fastener360 and excess portions of contracting member 226 being removed from thebody of the patient using tool 600. Severing of contracting member 226is performed in a manner as described hereinabove with reference toFIGS. 7A-E, mutatis mutandis.

Reference is now made to FIGS. 9A-D, which are schematic illustrationsof an example contracting-member-uptake tool 600 used to lock and secureannuloplasty structure 522 of FIGS. 8A-D in its contracted state andsubsequently, sever excess portions of contracting member 226.

FIG. 9A shows annuloplasty structure 522 in a partially, contractedstate. Contracting member 226 can be threaded along sleeve 26 and out ofa portion of sleeve 26 of structure 222. As described hereinabove,contracting member 226 can be threaded through tool 600 in a manner inwhich member 226 passes through a stop-coupler 672 of tool 600, throughdistal tip 631, through aligned ports 339 and 341 in distal end portion633 of tool 600, and through secondary tube 340.

In FIG. 9B, contracting member 226 has been pulled tight, andannuloplasty structure 522 has been contracted and in a tense,contracted state. Distal end portion 633 of tool 300 is brought closelyto annuloplasty structure 522 (e.g., tip 631 contacts housing 530 or isbrought close, as shown) in order to eject and deploy fastener 360within housing 530 in order to lock structure 522 in the contractedstate.

Once distal end portion 633 is brought into proximity with sleeve 26,trigger on the handle portion of tool 600 (similar to trigger 321 oftool 300 as shown in FIG. 6B) can be pulled partially, in order tofacilitate ejecting and deploying of contracting-member-fastener 360distally within housing 530 of annuloplasty structure 522.Fastener-ejector 335 is movable within distal end portion 633 ofcontracting-member-uptake tool 600. Movement of fastener-ejector 335converts contracting-member-fastener 360 (e.g., a clamping structurethereof) from its open state to its closed state to clamp ontocontracting member 226 passed therethrough. Fastener-ejector 335 iscoupled to stop-coupler 672 of tool 600 which screws into and engagesthreaded portion 572 of stop 570 in a manner in which when ejector 335is moved proximally within portion 633 of tool 600, stop 570 is pulledaway from fastener 630 and decoupled therefrom. Oncecontracting-member-fastener 360 is no longer held in the open state bystop 570, fastener 360 closes, as it tends to do, and clamps aroundcontracting member 226 passing therethrough.

In FIG. 9C, fastener-ejector 335 can be moved further proximally (inresponse to the further pulling of the trigger of the handle portion oftool 600), in order to sever excess portions of contracting member 226.Tool 600 can be shaped so as to define a cutting-facilitating edge 370in distal end portion 633 of tool 600. For some applications,cutting-facilitating edge 370 defines a sharp edge. While contractingmember 226 passes through aligned ports 339 and 341 in distal endportion 633 of tool 600, as shown in FIG. 9B, contracting member 226 isin proximity with cutting-facilitating edge 370. Movement offastener-ejector 335 proximally brings a cutting-facilitating edge 372of ejector 335 against cutting-facilitating edge 370 of tool 300, thussandwiching a portion of contracting member 226 between edges 370 and372, in order to sever and cut contracting member 226 extending throughports 339 and 341. For some applications, cutting-facilitating edge 372defines a sharp edge. FIG. 9C shows contracting member 226 severed oncecutting-facilitating edge 372 of ejector 335 has been brought againstcutting-facilitating edge 370 of tool 600.

As shown in FIG. 9D, once contracting member 226 has been severed, tool600 is withdrawn proximally, bringing together with it the excessportion of contracting member 226.

Reference is now made to FIGS. 8A-9D. System 510 provides anannuloplasty structure 522 (e.g., an annuloplasty ring structure, aclosed annuloplasty structure, a closed annuloplasty ring structure, anopen annuloplasty structure, a partial annuloplasty ring structure,etc.) in which housing 530 houses contracting-member-fastener 360,rather than fastener 360 being disposed outside sleeve 26. In such amanner, system 510 reduces the possibility of embolism and/or clotting.

Reference is now made to FIGS. 4A-9D. Contracting-member-uptake tools300 and 600 can be used to (1) apply tension to the contracting member,(2) deploy a lock in order to secure tension of the contracting member,and (3) subsequently cut and sever the contracting member of anyannuloplasty structure, e.g., a full annuloplasty ring structure, apartial annuloplasty ring structure, etc.

Reference is again made to FIGS. 8A-D and 9A-D. It is to be noted thatalthough tool 600 is described as being advanceable toward housing 530that is already coupled to annuloplasty structure 522, the scope hereinincludes tool 600 being coupled to housing 530 from a site outside thebody of the patient and being configured to deliver housing 530 alongcontracting member 226 to sleeve 26 of structure 522 that is alreadyimplanted at the annulus. For such applications, housing 530 isconfigured to be positionable against the primary body portion ofstructure 522.

Reference is now made to FIGS. 10A-B, which are schematic illustrationsof an example system 700 comprising an example contracting-member-uptaketool 702 which is configured to contract contracting member 226 andsever any excess portions of contracting member 226.

Except for the differences described hereinbelow,contracting-member-uptake tool 702 can be the same as or generallysimilar to contracting-member-uptake tools 300 and 600, describedhereinabove with reference to FIGS. 4A-9D, used to (1) apply tension tothe contracting member, (2) deploy a lock in order to secure tension ofthe contracting member, and (3) subsequently cut and sever thecontracting member of any annuloplasty structure, e.g., a full (orclosed) annuloplasty ring structure or a partial (or open) annuloplastyring structure.

Example contracting-member-uptake tool 702 is useable to uptakecontracting member 226 of an annuloplasty structure 730. Annuloplastystructure 730 can be the same as or generally similar to annuloplastystructures 222 or 522, described hereinabove with reference to FIGS.1-9D and like reference numerals refer to like parts. At this stage,annuloplasty structure 730 (e.g., an annuloplasty ring structure, aclosed annuloplasty structure, a closed annuloplasty ring structure, anopen annuloplasty structure, a partial annuloplasty ring structure,etc.) has been implanted along the annulus, as described hereinabovewith reference to FIGS. 3A-I. Once structure 730 has been implantedalong the annulus, contracting member 226 extends away from structure730 and through vasculature of the patient such that a proximal endportion of member 226 is disposed outside the body of the patient.

Except for the differences described hereinbelow, annuloplasty structure730 can be the same as or generally similar to annuloplasty structures222 and 522, described hereinabove with reference to FIGS. 1-9D and likereference numerals refer to like parts. Annuloplasty structure 730 canbe a full (or closed) or partial (or opened) annuloplasty structure.

As shown, structure 730 comprises sleeve 26 which defines the primarybody portion of structure 730. Contracting member 226 has a firstportion 732 extending along a longitudinal length of the primary bodyportion of annuloplasty structure 730. Contracting member 226 alsodefines a second portion 734 extending away from the primary bodyportion of annuloplasty structure 730.

Although tool 702 is used to implant a full (or closed) annuloplastystructure 730, as shown, the annuloplasty structure can be anannuloplasty ring structure and can comprise a partial (or open)annuloplasty structure.

For some applications, annuloplasty structure 730 is implemented usingtechniques described in U.S. application Ser. No. 12/341,960, filed Dec.22, 2008, which issued as U.S. Pat. No. 8,241,351, U.S. application Ser.No. 12/437,103, filed May 7, 2009 which issued as U.S. Pat. No.8,715,342, and/or U.S. application Ser. No. 12/689,635, filed Jan. 19,2010 which published as U.S. Pat. No. 8,545,553, both of which areassigned to the assignee of the present application and are incorporatedherein by reference.

Tool 702 can be configured in various ways. In some applications, tool702 comprises an elongate sheath 310. In some applications, sheath 310encases a primary tube 330 and a secondary tube 340 disposed alongsideprimary tube 330. For such applications, sheath 310 is shaped to as todefine secondary tube 340. Secondary tube 340 is shaped so as to definea longitudinal slit 740. Slit 740 facilitates ease of coupling andengagement of contracting member 226 within the lumen of tube 340. Slit740 also enables ease of release of contracting member 226 from withinthe lumen of tube 340. For some applications, slit 740 facilitates easeof coupling and/or release of the contracting-member-snare as describedhereinabove with reference to FIGS. 4A-B. For some applications, adistal-most section of slit 740 is at a longitudinal position along tube340 that is proximal to a distal-most end of tube 340, e.g., a part oftube 340 that is configured to be disposed proximally to a ventricle ofthe heart of the patient, such that leaking of blood from within theheart through slit 740 is prevented.

Tool 702 is used to deploy one or more (e.g., two as shown)contracting-member-fasteners 360 a and 360 b. Fasteners 360 a and 360 bare similar to or the same as fasteners 360 described hereinabove withreference to FIGS. 4A-9D. The use of two fasteners 360 a and 360 b canprovide redundant and more secure fastening of a perimeter of structure730 following contraction thereof. Fasteners 360 a and 360 b can bedisposed coaxially around a portion of contracting member 226

For some applications, a pushing tube (not shown) is used to deploycontracting-member-fasteners 360 a and 360 b. The pushing tube comprisesa semi-rigid material used to deploy by pushing fasteners 360 a and 360b. Fasteners 360 a and 360 b can be disposed coaxially around a portionof contracting member 226 and distally to a distal end of the pushingtube. For some applications, fasteners 360 a and 360 b are removablydisposed around a portion of the pushing tube.

Following the deployment of fasteners 360 a and 360 b, tool 702 is usedto sever any excess portions of contracting member 226, as describedhereinbelow with reference to tools 300 and 600 as described hereinabovewith reference to FIGS. 4A-9D.

For some applications, oversheath 710 is not used and tool 702 iscoupled to the annuloplasty structure using male and female couplings,as shown hereinbelow with reference to FIGS. 12, 13, and 15.

Reference is now made to FIGS. 11A-C, which are schematic illustrationsof an example system 800 comprising an example contracting-member-uptaketool 810 used to lock and secure annuloplasty structure 222 in itscontracted state and subsequently, sever excess portions of contractingmember 226, in accordance with some applications.

Except for the differences described hereinbelow,contracting-member-uptake tool 810 can be the same as or generallysimilar to contracting-member-uptake tools 300 and 600, describedhereinabove with reference to FIGS. 4A-9D, used to (1) apply tension tothe contracting member, (2) deploy a lock in order to secure tension ofthe contracting member, and (3) subsequently cut and sever thecontracting member of any annuloplasty structure, e.g., a full (orclosed) annuloplasty ring structure, a partial (or open) annuloplastystructure, etc.

FIG. 11A shows annuloplasty structure or annuloplasty ring structure 222in a non-contracted state. Distal tip 331 of tool 810 can be broughtclose to structure 222. Contracting member 226 can be threaded alongsleeve 26 and out of a portion of sleeve 26 of structure 222. Asdescribed hereinabove, contracting member 226 can be threaded throughtool 810 in a manner in which member 226 passes through distal tip 331,through contracting-member-fastener 360 that can be held in the openstate, such as by prongs 337 of stop 362, through aligned ports 339 and341 in distal end portion 333 of tool 810, and through secondary tube340. For some applications, the distal end portion of tool 810 issimilar to the distal end portion of tool 702 as described hereinabovewith reference to FIGS. 10A-B. For some applications, the distal endportion of tool 810 is similar to the distal end portion of tool 920 asshown hereinbelow with reference to FIGS. 12, 13, and 15. For suchapplications, tool 920 comprises male coupling 925 and annuloplastystructure 222 comprises housing 930 shaped so as to define femalecoupling 927.

Tool 810 comprises a proximal handle portion 820. Handle portion 820comprises a proximal contraction-facilitating knob 830. Knob 830 isfixedly coupled to a proximal end 832 of contracting member 226.Rotation of contraction-facilitating knob 830 as shown in FIG. 11A movesknob 830 proximally. As knob 830 is pulled proximally, contractingmember 226 is pulled proximally. Responsively, annuloplasty structure222 is contracted. Tool 810 comprise a gauge 834 indicating a level ofcontraction of the ring responsively to the number of rotations of knob830.

As shown in FIG. 11B, once distal tip 331 of tool 810 contacts sleeve 26of structure 222 (or for some applications a housing of annuloplastystructure, as described hereinabove with reference to FIGS. 12, 13, and15), tool 810 can be used to contract structure 222 by tool 810 pullingon contracting member 226 responsively to rotation of the knob 830 asdescribed hereinabove with reference to FIG. 11A. During contraction ofstructure 222, fastener 360 is not deployed.

In FIG. 11C, contracting member 226 has been pulled tight, andannuloplasty structure 222 has been contracted and in a tense,contracted state. Distal end portion 333 of tool 810 is then used toeject and deploy fastener 360 from within tool 810 in order to lockstructure 222 in the contracted state.

In some applications, once distal tip 331 contacts sleeve 26, a triggerknob 840 at handle portion 820 of tool 810 is pulled partially, in orderto facilitate ejecting and deploying of contracting-member-fastener 360from within a housing 332 of distal end portion 333. Fastener-ejector335 is movable within distal end portion 333 ofcontracting-member-uptake tool 810. A proximal portion of ejector 335 iscoupled to a distal portion of an actuating wire 842. A proximal end 844of actuating wire 842 is coupled to trigger knob 840. Proximal movementof trigger knob 840 pulls proximally on actuating wire 842, which, inturn, pulls maximally fastener-ejector 335. Movement of fastener-ejector335 proximally converts contracting-member-fastener 360 from its openstate to its closed state to clamp onto contracting member 226 passedtherethrough. Fastener-ejector 335 is coupled to prongs 337 of stop 362in a manner in which when ejector 335 is moved proximally within portion333, stop 362 is decoupled from contracting-member-fastener 360 asprongs 337 move proximally away from contracting-member-fastener 360.Once contracting-member-fastener 360 is no longer held in the open stateby stop 362, fastener 360 closes, as it tends to do, and clamps aroundcontracting member 226 passing therethrough.

Actuating wire 842 is disposed within an inner sheath 841 which runs thelength of elongate sheath 310. For such applications, as shown in FIGS.11A-C, elongate sheath 310 comprises a multi-lumen sheath defining (1) afirst lumen for passage therethrough of inner sheath 841 housing withinit actuating wire 842, and (2) a second lumen for passage therethroughof contracting member 226.

As shown in FIG. 11C, fastener 360 has been ejected and deployed fromwithin housing 332 of ejector 335. Subsequently, fastener-ejector 335 ismoved further proximally in response to the further pulling proximallyof trigger knob 840, in order to sever excess portions of contractingmember 226. Similar to tool 300 and 600 described hereinabove, tool 810is shaped so as to define a cutting-facilitating edge 370 in distal endportion 333 of tool 810. For some applications, cutting-facilitatingedge 370 defines a sharp edge. While contracting member 226 passesthrough aligned ports 339 and 341 in distal end portion 333 of tool 810,as shown in FIGS. 11A-C, contracting member 226 is in proximity withcutting-facilitating edge 370. Movement of fastener-ejector 335proximally brings a cutting-facilitating edge 372 of ejector 335 againstcutting-facilitating edge 370 of tool 810, thus sandwiching a portion ofcontracting member 226 between edges 370 and 372, in order to sever andcut contracting member 226 extending through ports 339 and 341. For someapplications, cutting-facilitating edge 372 defines a sharp edge. FIG.11C shows contracting member 226 severed once cutting-facilitating edge372 of ejector 335 has been brought against cutting-facilitating edge370 of tool 300.

Following the severing of contracting member 226, tool 810 is removedfrom the body of the patient by being withdrawn proximally, bringingtogether with it the excess portion of contracting member 226.

Reference is now made to FIGS. 11A-C. For some applications, triggerknob 840 is coupled to a safety mechanism in order to preventunintentional deployment of fastener 360.

Reference is now made to FIGS. 12A-C, which are schematic illustrationsof an example of a system 900 comprising an example annuloplastystructure 910 (e.g., an annuloplasty ring structure, a closedannuloplasty structure, a closed annuloplasty ring structure, an openannuloplasty structure, a partial annuloplasty ring structure, etc.)comprising a sleeve 26, a contracting member 226, and a lock 950.Implantable annuloplasty structure 910 comprises a primary body portion912. Contracting member 226 has a first portion 914 extending along alongitudinal length of primary body portion 912 of annuloplastystructure 910, and a second portion 916 extending away from primary bodyportion 912 of annuloplasty structure 910. Contracting member 226 isconfigured to adjust a perimeter of annuloplasty structure 910.

Except for the differences described hereinbelow, annuloplasty structure910 can be the same as or generally similar to annuloplasty structures222, 522, and 730 described hereinabove with reference to FIGS. 1-11Cand like reference numerals refer to like parts. Annuloplasty structure910 can be a full (or closed) or partial (or opened) annuloplastystructure.

Primary body portion 912 of structure 910 has a lateral wall and isshaped so as to define a recess 960 having a recess axis 940. Recess 960extends from an opening 932 in a first surface 934 of the lateral wallof primary body portion 912 toward an opposite second surface 936 of thelateral wall of the primary body portion 912 (illustrated in FIG. 12C).The lateral wall of primary body portion 912 extends away from recess960 along a longitudinal axis 942 that is at a non-zero angle withrespect to recess axis 940. Contracting member 226 extends throughrecess 960 and away from primary body portion 912 of annuloplastystructure 910 via recess 960.

Recess 960 is shaped so as to define a recess lumen 962. Recess lumen962 is disposed along recess axis 940.

For some applications, primary body portion 912 comprises a housing 930coupled to sleeve 26. For such applications, housing 930 defines atleast a portion of the lateral wall and housing 930 defines recess 960.Sleeve 26 defines the remaining portion of the lateral wall.

For some applications, structure 910 does not comprise a housing 930,and sleeve 26 defines the lateral wall.

Recess 960 is shaped so as to receive lock 950. Recess 960 isdimensioned so as to compress lock 950 when lock 950 is disposed atleast in part within recess 960. Lock 950 is shaped to as to define aseries of tapered segments 951. Each segment 951 having a longest lengthL1 of 0.2-1.5 mm. A proximal-most section of lock 950 has a length L2 of0.2-2 mm. Correspondingly, recess 960 corresponds to the shape of lock950 and is slightly smaller than the shape of lock 950 such that thewalls that define recess 960 compress lock 950 as it slides into recess960. That is, the section of recess 960 that receives longest length L1of segment 951 has a longest length L3 of 0.2-1.5 mm. A proximal-mostsection of recess 960 has a length L4 of 0.2-2 mm.

Lock 950 is shaped so as to define a lock lumen configured to surroundcontracting member 226. Lock 950 is shaped so as to define alongitudinal slit 952 which extends from a proximal surface of lock 950toward a distal surface of lock 950. For some applications, slit 952defines the lock lumen of lock 950. Slit 952 enables lock 950 to squeezeinto the smaller recess 960 and thereby be compressed. When lock 950 iscompressed, slit 952 enables lock 950 to close around contracting member226 and thereby lock 950 to contracting member 226.

For some applications (not shown), the lock lumen has a dimension (e.g.,a diameter) that is consistent along a length of the lock lumen from theproximal surface of lock 950 to a distal surface of lock 950.

As shown, for some applications, the lock lumen is shaped so as todefine a distal portion that is wider than a proximal portion of thelock lumen. For such applications, the proximal-most section of recess960 is narrower than any other portion of recess 960 distal to theproximal-most portion.

A delivery tool 920 is used to deliver lock 950 to recess 960. Exceptfor the differences described hereinbelow, delivery tool 920 can be thesame as or generally similar to tools 300, 600, 702, and 810 describedhereinabove with reference to FIGS. 4A-11C and like reference numeralsrefer to like parts. Tool 920 comprises a contracting-member severingsection 921 which can comprise elements of tools 300, 600, 702, and 810described hereinabove with respect to the cutting elements.

As shown in FIG. 12A, delivery tool 920 delivers annuloplasty structureor annuloplasty structure 910 and lock 950 together toward the annulus.Delivery tool 920 and contracting member 226 are slidable with respectto each other. When delivery tool 920 is coupled to annuloplastystructure 910, a portion of contracting member 226 (e.g., second portion916) is disposed within a lumen of delivery tool 920 and lock 950surrounds a part of the contracting member. When delivery tool 920 iscoupled to annuloplasty structure 910, lock 950 is disposed entirelyproximally to recess 960.

FIG. 12B shows partial position of lock 950 within a proximal portion ofrecess 960. During the partial positioning of lock 950, the distalportion of lock 950 is compressed (e.g., a distal-most tapered segment951). Since the distal portion of the lock lumen of lock 950 is widerthan the proximal portion of the lock lumen, as the distal portion oflock 950 is compressed within the proximal portion of recess 960, thedistal portion of lock 950 doesn't fully close around contracting member226 such that at this stage, lock 950 is not locked with respect tocontracting member 226 which would pull contracting member distally aslock 950 is pushed further distally within recess 960. Only once lock950 has been pushed entirely within recess 960, since the proximal-mostsection of recess 960 is narrower than any other portion of recess 960distal to the proximal-most portion, and since the lock lumen of lock950 is narrower at a proximal portion 953 of lock 950, at least proximalportion 953 of lock 950 closes around contracting member 226 in order tolock 950 to contracting member and, thereby, maintain the perimeter ofannuloplasty structure 910. That is, tool 920 pushes lock 950, oftenusing a lock-ejector 923 which is similar to fastener-ejector 335described hereinabove. Lock-ejector 923 is movable within a distal endportion of tool 920. Movement of lock-ejector 923 contacts and convertslock 950 from an open state (shown in FIG. 12A) to a closed state (shownin FIG. 12C) in order to clamp lock 950 onto contracting member 226passed therethrough.

As shown in FIG. 12C, lock 950 is shaped so as to fit entirely withinrecess 960. As described hereinabove with reference to tools 300, 600,702, and 810 described hereinabove with reference to FIGS. 4A-11C, tool920 is configured to sever excess portions of contracting member 226following the locking of lock 950 to contracting member 226 by beingpositioned within recess 960. That is, the distal end portion of tool920 is shaped so as to define a sharp edge, similar to edge 370 of tool300 as described hereinabove. Additionally, as described hereinabove,contracting member 226 is disposed in proximity to the sharp edge suchthat movement of lock-ejector 923 against the sharp edge severscontracting member 226 extending through lock 950.

Reference is now made to FIGS. 13A-C, which are schematic illustrationsof an example of a system 1000 comprising an example annuloplastystructure or annuloplasty structure 910 (e.g., an annuloplasty ringstructure, a closed annuloplasty structure, a closed annuloplasty ringstructure, an open annuloplasty structure, a partial annuloplasty ringstructure, etc.) comprising a sleeve 26, a contracting member 226, and alock 1950. Except for the differences described herein below, system1000 is the same or generally similar to system 900 as describedhereinabove with reference to FIGS. 12A-C with the exception that whendelivery tool 920 is coupled to annuloplasty structure 910, lock 1950 isdisposed at least in part and retained within recess a 1960. As shown, adistal-most tapered segment 951 is disposed within a proximal section ofrecess 1960. In such a manner, system 1000 reduces the possibility ofembolism and/or clotting.

Reference is now made to FIGS. 10A-13C. In FIG. 10A, tool 702 comprisesan oversheath 710 at least a distal portion of tool 702. Oversheath 710comprises grippers 720 which are configured to surround at least aportion of annuloplasty structure coupled to tool 702. For someapplications, any of tools 300, 600, and 810 described herein compriseoversheath 710 comprising grippers 720. Grippers 720 and oversheath 710are configured to provide a counterforce to the annuloplasty structureduring deployment of the fasteners 360 and/or lock 950 described herein,because in order to deploy the fasteners 360 and/or lock 950, thefasteners 360 and/or lock 950 are pushed by the tool. For someapplications, tools described herein do not comprise grippers 720.

Reference is now made to FIG. 14, which is a schematic illustration ofan example system 1100 comprising a lock 1110 configured to lock aperimeter of an annuloplasty structure (e.g., an annuloplasty ringstructure, a closed annuloplasty structure, a closed annuloplasty ringstructure, an open annuloplasty structure, a partial annuloplasty ringstructure, etc.), in accordance with some applications. Except for thedifferences described hereinbelow, lock 1110 can be generally similar tolock 950, described hereinabove with reference to FIGS. 12A-13C and likereference numerals refer to like parts. Slit 952 of lock 1110 is uniformalong a longitudinal axis of lock 1110 from a proximal end of lock 1110to a distal end of lock 1110. For some applications, as shown in FIGS.12A-13C, the lock lumen is uniform. For some applications, as shown inFIGS. 15A-C, the lock lumen is narrower at the proximal end portion andwider at the distal end portion of the lock.

Lock 1110 can be used to lock any annuloplasty structure describedherein, for example, lock 1110 can be used to lock any of annuloplastystructures 222, 522, 730, and 910 described hereinabove with referenceto FIGS. 1-13C.

A delivery tool can be used to deliver lock 1110 toward the annuloplastystructure or annuloplasty ring structure. The delivery tool can be thesame as or generally similar to tools 300, 600, 702, 810, and 920described hereinabove with reference to FIGS. 4A-13C and like referencenumerals refer to like parts. The delivery tool comprises acontracting-member severing section which can comprise elements of tools300, 600, 702, 810, and 920 described hereinabove with respect to thecutting elements.

Reference is now made to FIGS. 15A-C, which are schematic illustrationsof an example system 1480 comprising an example annuloplasty structure910 (e.g., an annuloplasty ring structure, a closed annuloplastystructure, a closed annuloplasty ring structure, an open annuloplastystructure, a partial annuloplasty ring structure, etc.) comprising asleeve 26, a contracting member 226, and a lock 1490, in accordance withsome applications. Except for the differences described herein below,system 1480 is the same or generally similar to system 1000 as describedhereinabove with reference to FIGS. 13A-C with the exception that lock1490 has a lumen that is narrower at the proximal end portion of lock1490 and wider at the distal end portion of lock 1490. Section A-A ofFIG. 15A shows the lock lumen being wider around contracting member 226at the proximal end portion of lock 1490 than a width of the lock lumenaround contracting member 226 at the distal end portion of lock 1490shown in Section B-B. As shown in FIG. 15C, once lock 1490 is disposedentirely within recess 960, the proximal end portion closes tightlyaround contracting member 226, as shown in Section C-C, while the distalend portion closes around contracting member 226, which may not close astightly as the proximal end portion closes around contracting member226, as shown in Section D-D.

As shown, lock 1490 is shaped so as to define slit 952 that is narrowerat the proximal end portion of lock 1490 and wider at the distal endportion of lock 1490.

For some applications, lock 1490 is shaped so as to define slit 952 thatis uniform along the length of lock 1490 as shown in FIG. 14.

For some applications, when delivery tool 920 is coupled to annuloplastystructure 910, lock 1490 is disposed entirely proximally to recess 1960,as shown in FIGS. 12A-C.

Reference is now made to FIG. 16, which is a schematic illustration ofan example system 1200 comprising an example annuloplasty structure 1210(e.g., an annuloplasty ring structure, a closed annuloplasty structure,a closed annuloplasty ring structure, an open annuloplasty structure, apartial annuloplasty ring structure, etc.) comprising a sleeve 26, acontracting member 226, and a lock 1220. Implantable annuloplastystructure 1210 comprises a primary body portion. Contracting member 226has a first portion extending along a longitudinal length of the primarybody portion of annuloplasty structure 1210, and a second portionextending away from the primary portion of annuloplasty structure 1210.Contracting member 226 is configured to adjust a perimeter ofannuloplasty structure 1210.

Except for the differences described hereinbelow, annuloplasty structure1210 can be the same as or generally similar to annuloplasty structures222, 522, 730, and 910 described hereinabove with reference to FIGS.1-15C and like reference numerals refer to like parts. Annuloplastystructure 1210 can be a full (or closed) or partial (or opened)annuloplasty structure.

Structure 1210 comprises a housing 1202 shaped so as to define a lateralwall and is shaped so as to define a recess 1230 having a recess axis.Recess 1230 extends from an opening in a first surface of the housingtoward an opposite second surface of housing 1202. Housing 1202 isshaped so as to provide a contracting-member-lumen wall 1205 which isdisposed along a contracting-member lumen 1204. Contracting-member lumen1204 is disposed at a non-zero angle with respect to a recess axis 1207of recess 1230. Recess 1230 is shaped so as to define a recess lumenthat is disposed along recess axis 1207.

Lock 1220 is shaped so as to define a lock-threaded-portion 1222.Housing 1202 of annuloplasty structure 1210 is shaped so as to defineannuloplasty-structure-threaded-portion 1232 configured to engage withlock-threaded-portion 1222. In order to advance lock 1220 within recess1230 of housing 1202, the physician uses a delivery tool in order toscrew lock 1220 within housing 1202. The delivery tool can be the sameas or generally similar to tools 300, 600, 702, 810, and 920 describedhereinabove with reference to FIGS. 4A-13C and like reference numeralsrefer to like parts. The delivery tool comprises a contracting-membersevering section which can comprise elements of tools 300, 600, 702,810, and 920 described hereinabove with respect to the cutting elements.

When lock 1220 is disposed within the recess, a distal surface of adistal end of lock 1220 is configured to pinch a first portion ofcontracting member 226 against contracting-member-lumen wall 1205 inorder to lock contracting member 226 at least a first pinching point1212.

For some applications, housing 1202 defines at least a portion of alateral wall of the annuloplasty structure 1210, and housing 1202defines recess 1230.

Lock 1220 is shaped so as to define a lock lumen 1221 configured tosurround contracting member 226. Lock 1220 is shaped so as to define alongitudinal slit which extends from a proximal surface of lock 1220toward a distal surface of lock 1220. For some applications, the slitdefines lock lumen 1221 of lock 1220. The slit enables lock 1220 tosqueeze into the smaller recess 1230 and thereby be compressed. Whenlock 1220 is compressed, the slit enables lock 1220 to close aroundcontracting member 226 and thereby lock 1220 to contracting member 226.

For some applications, lock lumen 1221 has a dimension (e.g., adiameter) that is consistent along a length of lock lumen 1221 from theproximal surface of lock 1220 to a distal surface of lock 1220.

Reference is now made to FIGS. 15A-C, and 16. For some applications,lock lumen 1221 of lock 1220 is shaped so as to define a distal portionthat is wider than a proximal portion of lock lumen 1221. For suchapplications, the proximal-most section of recess 1230 can be narrowerthan any other portion of recess 1230 distal to the proximal-mostportion.

Reference is now made to FIGS. 12A-C, 13A-C, 15A-C, and 16. For someapplications, the slit of lock 1220 is wider at the distal end portionof lock 1220 and narrower at the proximal end portion of lock 1220.

Reference is now made to FIGS. 14 and 16. For some applications, theslit of lock 1220 is uniform along the length of the slit. For someapplications, lock lumen 1221 is uniform along the length of lock 1220.

Reference is now made to FIG. 17, which is a schematic illustration ofan example system 1300 comprising an example annuloplasty structure 1310(e.g., an annuloplasty ring structure, a closed annuloplasty structure,a closed annuloplasty ring structure, an open annuloplasty structure, apartial annuloplasty ring structure, etc.) comprising a sleeve 26, acontracting member 226, and a lock 1320. Implantable annuloplastystructure 1310 comprises a primary body portion. Contracting member 226has a first portion extending along a longitudinal length of the primarybody portion of annuloplasty structure 1310, and a second portionextending away from the primary portion of annuloplasty structure 1310.Contracting member 226 is configured to adjust a perimeter ofannuloplasty structure 1310.

Except for the differences described hereinbelow, annuloplasty structure1310 can be the same as or generally similar to annuloplasty structures222, 522, 730, and 910 described hereinabove with reference to FIGS.1-15C and like reference numerals refer to like parts. Annuloplastystructure 1310 can be a full (or closed) or partial (or opened)annuloplasty structure.

Structure 1310 comprises a housing 1302 shaped so as to define a lateralwall and is shaped so as to define a recess 1330 having a recess axis.Recess 1330 extends from an opening in a first surface of the housingtoward an opposite second surface of housing 1302. Housing 1302 isshaped so as to provide a contracting-member-lumen wall 1305 which isdisposed along a contracting-member lumen 1304. Contracting-member lumen1304 is disposed at a non-zero angle with respect to a recess axis 1307of recess 1330. Recess 1330 is shaped so as to define a recess lumenthat is disposed along recess axis 1307.

Lock 1320 is shaped so as to define a lock-threaded-portion 1222.Housing 1302 of annuloplasty structure 1310 is shaped so as to defineannuloplasty-structure-threaded-portion 1332 configured to engage withlock-threaded-portion 1322. In order to advance lock 1320 within recess1330 of housing 1302, the physician uses a delivery tool in order toscrew lock 1320 within housing 1302. The delivery tool can be the sameas or generally similar to tools 300, 600, 702, 810, and 920 describedhereinabove with reference to FIGS. 4A-13C and like reference numeralsrefer to like parts. The delivery tool comprises a contracting-membersevering section which can comprise elements of tools 300, 600, 702,810, and 920 described hereinabove with respect to the cutting elements.

When lock 1320 is disposed within the recess, a distal surface of adistal end of lock 1320 is configured to pinch a first portion ofcontracting member 226 against contracting-member-lumen wall 1305 inorder to lock contracting member 226 at least a first pinching point1312. Lock 1320 is shaped so as to define a lock lumen 1321 along alongitudinal length and a lock-distal-tapered-portion 1334. Housing 1302and recess 1330 are shaped so as to define arecess-distal-tapered-portion 1324. When lock 1320 is disposed withinrecess 1330, and lock-distal-tapered-portion 1334 is withinrecess-distal-tapered-portion 1324, recess-distal-tapered-portion 1324is configured to compress lock-distal-tapered-portion 1334 which, inturn, is configured to pinch a second portion of contracting member 226within lock lumen 1321 at recess-distal-tapered-portion 1324 in order tolock contracting member 226 at least a second pinching point 1314.

For some applications, housing 1302 defines at least a portion of alateral wall of the annuloplasty structure 1310, and housing 1302defines recess 1330.

Lock lumen 1321 configured to surround contracting member 226. Lock 1320is shaped so as to define a longitudinal slit which extends from aproximal surface of lock 1320 toward a distal surface of lock 1320. Forsome applications, the slit defines lock lumen 1321 of lock 1320. Theslit enables lock 1320 to squeeze into the smaller recess 1330 andthereby be compressed. When lock 1320 is compressed, the slit enableslock 1320 to close around contracting member 226 and thereby lock 1320to contracting member 226.

For some applications, lock lumen 1321 has a dimension (e.g., adiameter) that is consistent along a length of lock lumen 1321 from theproximal surface of lock 1320 to a distal surface of lock 1320.

Reference is now made to FIGS. 15A-C, and 17. For some applications,lock lumen 1321 of lock 1320 is shaped so as to define a distal portionthat is wider than a proximal portion of lock lumen 1321. For suchapplications, the proximal-most section of recess 1330 can be narrowerthan any other portion of recess 1330 distal to the proximal-mostportion.

Reference is now made to FIGS. 12A-C, 13A-C, 15A-C, and 17. For someapplications, the slit of lock 1320 is wider at the distal end portionof lock 1320 and narrower at the proximal end portion of lock 1320.

Reference is now made to FIGS. 14 and 17. For some applications, theslit of lock 1320 is uniform along the length of the slit. For someapplications, lock lumen 1321 is uniform along the length of lock 1320.

Reference is now made to FIGS. 16-17. Systems 1200 and 1300 provide alocking assembly which allows for the operating physician to readjustthe perimeter of the annuloplasty structure post-locking. For example,if the physician would like to readjust once locks 1220 and 1320 are inplace, the physician is able to unscrew locks 1220 and 1230 respectivelyin order to readjust the perimeter of the annuloplasty structure bygiving slack to or tightening contracting member 226 without disengaginglocks 1220 and 1300 from the respective recess 1230 and 1330.Subsequently to the readjusting of contracting member 226, locks 1220and 1320 are repositioned within the respective recess 1230 and 1330.

Reference is now made to FIG. 18, which is a schematic illustration ofan example of a system 1350 for contracting annulus 240 of the patientusing an annuloplasty structure 522 (e.g., an annuloplasty ringstructure, a closed annuloplasty structure, a closed annuloplasty ringstructure, an open annuloplasty structure, a partial annuloplasty ringstructure, etc.), which can comprise a housing 530. Housing 530 canhouse a contracting-member-fastener 1360. Except for the differencesdescribed hereinbelow, annuloplasty structure 522 can be the same as orgenerally similar to annuloplasty structure 222, described hereinabovewith reference to FIGS. 1-7E and like reference numerals refer to likeparts.

Annuloplasty structure or annuloplasty ring structure 522 can comprisesleeve 26 which can define a primary body portion of structure 522.Structure 522 comprises contracting member 226 having a first portionextending along a longitudinal length of the primary body portion ofannuloplasty structure 522. Contracting member 226 also defines a secondportion extending away from the primary body portion of annuloplastystructure 522.

Contracting member 226 can extend through housing 530 and through a stop570 (e.g., a holder) that is disposed within an opening ofcontracting-member-fastener 1360. Stop 570 is shown as being cylindricalby way of illustration and not limitation. The outer surface of stop 570maintains fastener 1360 in the open state. Stop 570 is shaped so as todefine a threaded portion which enables coupling thereto ofcontracting-member-uptake tool 600, as is described hereinabove.

Annuloplasty structure or annuloplasty ring structure 522 is implantedas described hereinabove with reference to FIGS. 3A-I using the systemdescribed hereinabove with reference to FIGS. 1-3I.

Housing 530 can be coupled to sleeve 26 of structure 522 at any suitablelocation along structure 522. For example, housing 530 can be coupled tosleeve 26 of structure 522 at a portion of structure 522 in a vicinityof a left fibrous trigone of the valve, as shown. For some applications,housing 530 can be coupled to sleeve 26 of structure 522 at a portion ofstructure 522 in a vicinity of a right fibrous trigone of the valve. Forsome applications, housing 530 can be coupled to sleeve 26 of structure522 at a middle portion of structure 522. As shown, housing 530 can becoupled to a lateral surface of sleeve 26. In such applications, housing530 does not block them lumen of sleeve 26 of structure 522.

Fastener 1360 is generally similar to fastener 360 of FIGS. 8A-D, withthe exception that fastener 1360 is shaped so as to define intersectingslits 1362 which form the opening of fastener 1360 through whichcontracting member 226 passes into a generally “X” or generally “+”(plus) shape.

FIG. 18 shows contracting member 226 being severed proximal to fastener1360 and excess portions of contracting member 226 being removed fromthe body of the patient using tool 600. Severing of contracting member226 can be performed in a manner as described hereinabove with referenceto FIGS. 7A-E, mutatis mutandis.

Reference is now made to FIGS. 19A-B, which are schematic illustrationsof an example of a system 1400 for contracting the annulus of thepatient using an annuloplasty structure (e.g., an annuloplasty ringstructure, a closed annuloplasty structure, a closed annuloplasty ringstructure, an open annuloplasty structure, a partial annuloplasty ringstructure, etc.), which can be coupled to a housing 1430. Housing 1430can house a contracting-member-fastener 1460. For some applications, theannuloplasty structure can be the same as or generally similar toannuloplasty structure 222, described hereinabove with reference toFIGS. 1-7E and like reference numerals refer to like parts. For someapplications, the annuloplasty structure comprises housing 1430. Forsome applications, housing 1430 is discrete from the annuloplastystructure and deliverable and couplable to the annuloplasty structureonly once the annuloplasty structure has been anchored to the annulus.

Housing 1430 can be coupled to the sleeve 26 of the annuloplastystructure at any suitable location along the annuloplasty structure. Forexample, housing 1430 can be coupled to the sleeve 26 of theannuloplasty structure at a portion of the annuloplasty structure in avicinity of a left fibrous trigone of the valve, as shown. For someapplications, housing 1430 can be coupled to the sleeve of theannuloplasty structure at a portion of the annuloplasty structure in avicinity of a right fibrous trigone of the valve. For some applications,housing 1430 can be coupled to the sleeve of the annuloplasty structureat a middle portion of the annuloplasty structure. As shown, housing1430 can be coupled to a lateral surface of the sleeve. In suchapplications, housing 1430 does not block them lumen of the sleeve ofthe annuloplasty structure.

The annuloplasty structure or annuloplasty ring structure can comprisethe sleeve which can define a primary body portion of the structure. Thestructure comprises contracting member 226 having a first portionextending along a longitudinal length of the primary body portion ofannuloplasty structure. The contracting member also defines a secondportion extending away from the primary body portion of the annuloplastystructure.

Fastener 1460 is shaped so as to define a generally-rectangular, planarclip comprising a super-elastic material, e.g., nitinol. Fastener 1460comprises a deformable element shaped so as to define a plurality ofslits which are surrounded by a plurality of flexible legs 1462 whichenable the clip to transition between slanted (FIG. 19A) and straight(FIG. 19B) states. The contracting-wire-engaging surface of the clip isshaped to define a plurality of teeth 1464. For some applications, teeth1464 are jagged. For some applications, the upper surface of the clipdoes not comprise teeth 1464 and is flat. Teeth 1464 are configured toincrease friction between contracting member 226 and fastener 1460.

Fastener 1460 comprises a clamping structure that is (a) biased towardassuming a closed state (FIG. 19B). In the closed state, the clampingstructure is configured to clamp onto contracting member 226 passedtherethrough, and (b) can be flexed to an open state (FIG. 19A) throughwhich contracting member 226 can move.

Contracting member 226 can extend through a channel 1434 of housing 1430and through a stop 1470 (e.g., a holder) that is disposed within anopening of contracting-member-fastener 1460. Channel 1434 extends alonga longitudinal axis 1410 of housing 1430. Stop 1470 can be shaped so asto define a lumen therethrough for surrounding contracting member 226and is shown as being shaped to as to define a larger cylindricalsection that is engageable by a tool, and a narrower cylindrical engager1472. Engager 1472 can be shaped so as to fit snugly within channel 1434such that it pushes against the contracting-wire-engaging surface of theclip and maintains fastener 1460 in a slanted state, i.e., an unlockedstate of fastener 1460. In the slanted state as shown in FIG. 19A, theclip is deformed and does not push against contracting member 226. Inthe slanted state, contracting member 226 is free to move with respectto fastener 1460, housing 1430, and stop 1470. Contracting member 226 ispulled until it sufficiently contracts the annuloplasty structure.

In FIG. 19B, stop 1470 has been decoupled and removed from housing 1430.In the absence of force applied to the contracting-wire-engaging surfaceof the clip by engager 1472, the clip returns to its resting, straightstate and traps contracting member 226 between thecontracting-wire-engaging surface of the clip and a surface 1432 ofhousing 1430, e.g., an inner wall. As such, fastener 1460 is now in alocked state in which the clip locks and crimps contracting member 226.

Reference is now made to FIGS. 20A-F, which are schematic illustrationsof an example of a portion of a multi-component tubular system 1500comprising a contracting-member-severing tool 1502 and acontracting-member-uptake tool 1600, described hereinbelow withreference to FIGS. 21A-26B. Contracting member 226 is threaded throughand passes through contracting-member severing tool 1502 and throughcontracting-member-uptake tool 1600. Contracting member 226 can beensnared by tool 1502 using a snare as described herein above withregard to snare 350 with reference to FIGS. 4A-5D. Tool 1502 can beadvanced along contracting member 226 toward an annuloplasty structure1522 (e.g., an annuloplasty ring structure, a closed annuloplastystructure, a closed annuloplasty ring structure, an open annuloplastystructure, a partial annuloplasty ring structure, etc.). For someapplications, tool 1502 is advanced toward a housing 1530 that isalready coupled to structure 1522, in a manner similar to tool 300advancing along contracting member 226, as described hereinabove withreference to FIGS. 4A-5D. Annuloplasty structure 1522 can comprise aflexible primary body portion. Contracting member 226 has a firstportion extending along a longitudinal length of the primary bodyportion. A second portion of contracting member 226 can extend away fromthe primary body portion of annuloplasty structure 1522 and outside thebody of the patient.

System 1500 is used to contract the annulus of the patient usingannuloplasty structure 1522 (e.g., an annuloplasty ring structure, aclosed annuloplasty structure, a closed annuloplasty ring structure, anopen annuloplasty structure, a partial annuloplasty ring structure,etc.), which can comprise a housing 1530. Housing 1530 can house acontracting-member-fastener 1560. Except for the differences describedhereinbelow, annuloplasty structure 1522 can be the same as or generallysimilar to annuloplasty structure 222, described hereinabove withreference to FIGS. 1-7E and like reference numerals refer to like parts.

It is to be noted that fastener 1560 can comprise fasteners 360described hereinabove with reference to FIGS. 4A-B, 7A-E, 8A-D, 9A-D,10A-B, and 11A-C, lock 950 described hereinabove with reference to FIGS.12A-C, lock 1950 described hereinabove with reference to FIGS. 12A-C,lock 1110 described hereinabove with reference to FIG. 14, lock 1490described hereinabove with reference to FIGS. 15A-C, lock 1220 describedhereinabove with reference to FIG. 16, lock 1320 described hereinabovewith reference to FIG. 17, or any other fastener, lock, and/or crimpknown in the art.

Annuloplasty structure or annuloplasty ring structure 1522 can comprisesleeve 26 which can define a primary body portion of structure 1522.Structure 1522 comprises contracting member 226 having a first portionextending along a longitudinal length of the primary body portion ofannuloplasty structure 1522. Contracting member 226 also defines asecond portion extending away from the primary body portion ofannuloplasty structure 1522.

Contracting member 226 can extend through housing 1530 and through astop 1570 (e.g., a holder) that is disposed within an opening ofcontracting-member-fastener 1560. Stop 1570 is shaped so as to define alumen therethrough for surrounding contracting member 226 and is shownas being shaped to as to define a larger cylindrical section that isengageable by a tool, and a narrower cylindrical engager 1574. The outersurface of engager 1574 maintains fastener 1560 in the open state, asshown in FIGS. 20A-D. Stop 1570 is shaped so as to define an overhang1572, which enables coupling thereto of contracting-member-severing tool1502, as is described hereinbelow.

Annuloplasty structure or annuloplasty ring structure 1522 is implantedas described hereinabove with reference to FIGS. 3A-I using the systemdescribed hereinabove with reference to FIGS. 1-3I.

Housing 1530 can be coupled to sleeve 26 of structure 1522 at anysuitable location along structure 1522. For example, housing 1530 can becoupled to sleeve 26 of structure 1522 at a portion of structure 1522 ina vicinity of a left fibrous trigone of the valve, as shown. For someapplications, housing 1530 can be coupled to sleeve 26 of structure 1522at a portion of structure 1522 in a vicinity of a right fibrous trigoneof the valve. For some applications, housing 1530 can be coupled tosleeve 26 of structure 1522 at a middle portion of structure 1522. Asshown, housing 1530 can be coupled to a lateral surface of sleeve 26. Insuch applications, housing 1530 does not block them lumen of sleeve 26of structure 1522.

FIG. 20A shows contracting-member-severing tool 1502 through whichcontracting member 226 has been threaded. Contracting member 226 can beensnared by tool 1502 using a snare as described herein above withregard to snare 350 with reference to FIGS. 4A-5D. Tool 1502 can beadvanced along contracting member 226 toward housing 1530 of structure1522, in a manner similar to tool 300 advancing along contracting member226, as described hereinabove with reference to FIGS. 4A-5D.

Once tool 1502 is threaded along contracting member 226, contractingmember 226 extends from sleeve 26, through engager 1574, through theproximal portion of stop 1570, through cutting elements 1510 and 1520 oftool 1502, and through the remaining proximal portion of tool 1502. Assuch, contracting member 226 is disposed in a vicinity of the cuttingelements. Contracting member 226 is disposed along a longitudinal axis1511 of tool 1502 along the entire length of tool 1502. The relativespatial orientation of the components of tool 1502 enable contractingmember 226 to pass straightly and directly though the lumen of tool 1502and along axis 1511 without taking a winding path through tool 1502.This direct and unwinding path of member 226 through tool 1502 reducesfriction of member 226 as it moves within tool 1502. This direct pathfor contracting member 226 is enabled due to the orientation ofcomponents of tool 1502, as opposed to the winding path member 226through tools 300, 600, 810, and 920 described hereinabove. The reducesfriction on contracting member 226 reduces noise during the measurementof tension of the contracting member 226, as described hereinbelow withreference to FIGS. 21A-26B.

Tool 1502 comprises an inner tube 1504 that is slidable with respect toan outer sleeve portion 1508. The distal end of inner tube 1504 isshaped so as to define graspers 1505, or fastener-ejectors. Since thedistal end portion of tube 1504 is slotted, and since graspers 1505 aresloped, graspers 1505 have a tendency to be pushed radially outwardly inthe presence of a force applied thereto by overhang 1572. Once tube 1504is pushed sufficiently distally, graspers 1505 pass distally aroundoverhang 1572 and close around stop 1570 at a site distal to overhang1572, as shown in FIG. 20B. Graspers 1505 provide the primary andinitial coupling and locking of tool 1502 to housing 1530 by grippingoverhang 1572.

Tool 1502 comprises a static cutting element 1510 and a moveable,dynamic cutting element 1520. Static cutting element 1510 is shaped soas to define a concave cutting surface 1512 (i.e., a sharp edge), anddynamic cutting element 1520 is shaped so as to define a concave cuttingsurface 1521 (i.e., a sharp edge) which opposes concave cutting surface1512 of static cutting element 1510. As is described hereinbelow,dynamic cutting element 1520 slides proximally and diagonally withrespect to static cutting element 1510, along concave cutting surface1512 of static cutting element 1510.

Once stop 1570 is engaged by inner tube 1504, outer sleeve portion 1508is moved distally along inner tube 1504 and toward housing 1530 until adistal end of outer sleeve portion 1508 contacts a proximal end ofhousing 1530, as shown in FIG. 20C. Such distal movement of portion 1508locks in place tube 1504 with respect to stop 1570 and thereby locks inplace tool 1502 with respect to housing 1530. Since graspers 1505 areslanted, they are able to slide proximally around overhang 1572 inresponse to proximal pulling of tool 1502. Thus, surrounding the slotteddistal end portion of tube 1504 and surrounding graspers 1505 of tube1504 by outer sleeve portion 1508 prevents radial movement of graspers1505 responsively to application of a proximal pulling force to stop1570 by tool 1502 during the release of fastener 1560 in order to lockcontracting member 226 in place and retain annuloplasty structure 1522in a tensed state, as will be described hereinbelow. Outer sleeveportion 1508 thus locks graspers 1505 with respect to overhang 1572 andprovides a secondary coupling and locking of tool 1502 to housing 1530.

Static cutting element 1510 comprises a pin 1513 which slides proximallyand distally within a slit 1515 of tube 1404. As such, static cuttingelement 1510 is coupled to tube 1404, and to the tube surrounding tube1404. That is, pin 1513 is coupled to outer sleeve portion 1508. Asouter sleeve portion 1508 is moved distally, as shown in FIG. 20C, pin1513 moves distally within slit 151 and static cutting element 1510 anddynamic cutting element 1520 are pushed distally within tube 1404. Inthis state, a distal surface 1523 of dynamic cutting element 1520 isstill disposed at a distance from a proximal surface 1571 of stop 1570.

FIG. 20D shows contracting of annuloplasty structure 1522 responsivelyto proximal pulling of contracting member 226 by tool 1502. During thepulling of contracting member 226, tool 1502 remains coupled to housing1530 due to graspers 1505 grasping overhang 1572 while outer sleeveportion 1508 surrounds the distal portion of inner tube 1504 andsurrounds graspers 1505.

Tool 1502 can comprise a contracting-member-uptake device 322 of tool300 as described hereinabove with reference to FIGS. 4A-B. Thecontracting-member-uptake device can be used to contract contractingmember 226. Once contracting member 226 is contracted and structure 1522is contracted, as shown in FIG. 20D, tool 1502 removes stop 1570 bypulling stop 1570 proximally away from fastener 1560, as is described inFIG. 20E. While maintaining distal force to outer sleeve portion 1508,tube 1404 is pulled proximally with respect to portion 1508. Pulling oftube 1504 proximally pulls on stop 1570 since graspers 1505 maintaingrasp on overhang 1572 of stop 1570 due to the presence of outer sleeveportion 1508. During the pulling of tube 1504 proximally, outer sleeveportion 1508 prevents radial outward movement of graspers 1505 asproximal force is being applied to tube 1504. Tube 1504 is pulledproximally until stop 1570 is disengaged from housing 1530, i.e., untilengager 1574 of stop 1570 is decoupled and disengaged from fastener1560, as shown in FIG. 20E. Since fastener 1560 tends to close, in theabsence of stop 1570, fastener 1560 closes and clamps around contractingmember 226 passing through fastener 1560. In such a manner, structure1522 is locked by fastener 1560, and the contracted state of structure1522 is maintained.

As stop 1570 is pulled proximally, proximal surface of stop 1570 hammersinto distal surface 1523 of dynamic cutting element 1520. Responsivelyto the pushing of stop 1570 against dynamic cutting element 1520,dynamic cutting element 1520 is pushed proximally such that dynamiccutting element 1520 moves diagonally proximally. Cutting surface 1521of dynamic cutting element 1520 and cutting element 1520 slidediagonally proximally along cutting surface 1512 of static cuttingelement 1510. The portion of contracting member 226 disposed betweencutting surfaces 1512 and 1521 is severed. Since cutting surfaces 1512and 1521 are concave and face each other, surfaces 1512 and 1521compress contracting member 226 during the cutting, and thereby,contracting member 226 is severed cleanly and without fraying.

Thus, tool 1502 is arranged such that tool 1502 advantageously providesa safety mechanism by which contracting member 226 can only be severedby proximal force applied thereto by stop 1570 after fastener 1560 hasbeen transitioned into the fastened, or locked, state and locks in placecontracting member 226. That is, tool 1502 cannot inadvertently severcontracting member 226 all the while tool 1502 is not coupled to stop1570 and all the while stop 1570 does not push against cutting element1520. In one swift motion, tool 1502 (1) locks in place contractingmember 226 by transitioning fastener 1560 into the locked state, and (2)severs contracting member 226.

FIG. 20F shows contracting member 226 after having been severed proximalto fastener 1560, and excess portions of contracting member 226 beingremoved from the body of the patient using tool 1502. The entire tool1502 is pulled proximally in order to decouple tool 1502 from housing1530 and from structure 1522 carrying stop 1570 within the lumen of tool1502. Since stop 1570 is no longer coupled to housing 1530, a simpleproximal pull on tool 1502 is enough to decouple tool 1502 fromannuloplasty structure 1522.

Reference is again made to FIGS. 20A-F. It is to be noted that althoughtool 1502 is described as being advanceable toward housing 1530 that isalready coupled to annuloplasty structure 1522, the scope hereinincludes tool 1502 being coupled to housing 1530 from a site outside thebody of the patient and being configured to deliver housing 1530 alongcontracting member 226 to sleeve 26 of structure 1522 that is alreadyimplanted at the annulus. For such applications, housing 1530 isconfigured to be positionable against the primary body portion ofstructure 1522.

Reference is now made to FIGS. 21A-26B, which are schematicillustrations of another portion of multi-component tubular system 1500,described hereinabove with reference to FIGS. 20A-F, comprisingcontracting-member-uptake tool 1600, which is configured to contractflexible elongated contracting member 226, in accordance with someapplications. FIGS. 21A-B show contracting-member-uptake tool 1600before insertion of flexible elongated contracting member 226, and FIGS.22A-26B show contracting-member-uptake tool 1600 after insertion offlexible elongated contracting member 226.

Multi-component tubular system 1500 is used with an implant comprisingan implantable structure and flexible elongated contracting member 226that extends away from the implantable structure. The implant maycomprise any of the implants described herein, such as implantableannuloplasty structure 222, which may, for example, comprise flexiblesleeve 26. Alternatively, the implant may comprise another implant knownin the art (including those described in the patents and patentapplication publications incorporated hereinbelow by reference), whichmay or may not comprise a sleeve.

Contracting-member-uptake tool 1600 comprises a handle portion 1620,which optionally may be supported by a stand, such as describedhereinabove with reference to FIGS. 1-2. Handle portion 1620 cancomprise one, some, or all of:

-   -   an outer housing 1632, which can be shaped ergonomically for        holding by a user (e.g., a physician, healthcare professional,        etc.);    -   a tubular shaft 1634, disposed at least partially within outer        housing 1632;        -   an inner shaft 1636, which (a) is partially disposed within            a proximal longitudinal portion 1637 of tubular shaft 1634,            such that inner shaft 1636 is axially slidable with respect            to tubular shaft 1634, and (b) is shaped so as to define an            inner-shaft contracting-member-receiving channel 1638;        -   a distal force applicator 1642, which (a) is disposed at            least partially within a distal longitudinal portion of            tubular shaft 1634, and (b) is shaped so as to define a            distal-force-applicator contracting-member-receiving channel            1644, which allows sliding of contracting member 226            therethrough;    -   a spring 1646, which is disposed within tubular shaft 1634,        connecting distal force applicator 1642 and a distal portion        1647 of inner shaft 1636; and        -   a contraction-facilitating knob 1630, which is accessible            from outside outer housing 1632.

Handle portion 1620 is shaped so as to define a handlecontracting-member-receiving channel 1650 from a distal end through to aproximal end of handle portion 1620 (as used in the present application,including in the claims, “proximal” means toward the user, i.e., awayfrom the implant; with reference to FIGS. 21A-26B, “proximal” means tothe right in the drawings). Handle contracting-member-receiving channel1650 includes inner-shaft contracting-member-receiving channel 1638,distal-force-applicator contracting-member-receiving channel 1644, andoptionally additional contracting-member-receiving channels of handleportion 1620. A portion of contracting member 226 is threaded throughhandle contracting-member-receiving channel 1650 either after or beforethe implantable structure and contracting member 226 are advanced towardthe heart of the patient.

Inner shaft 1636 can comprise a lock 1640, which is configured (i) whenin an unlocked state, to allow sliding of contracting member 226 withrespect to inner-shaft contracting-member-receiving channel 1638, and(ii) when in a locked state, to axially lock contracting member 226 withrespect to inner shaft 1636. Optionally, lock 1640 applies friction toaxially lock contracting member 226 with respect to inner shaft 1636,such as using a set screw or a lever, as is known in the art.

Handle portion 1620 is configured such that actuation ofcontraction-facilitating knob 1630, when contracting member 226 isdisposed passing entirely through handle contracting-member-receivingchannel 1650 and lock 1640 is in the locked state, causes handle portion1620 to uptake successive portions of contracting member 226. FIGS.22A-B show handle portion 1620 before actuation ofcontraction-facilitating knob 1630, when contracting member 226 isdisposed passing entirely through handle contracting-member-receivingchannel 1650 and lock 1640 is in the locked state. FIGS. 23A-B, 24A-B,and 25A-B show handle portion 1620 after successive levels of actuationof contraction-facilitating knob 1630, as described below.

As shown in FIGS. 21A-B and 22A-B, before initial actuation ofcontraction-facilitating knob 1630, the portion of contracting member226 between handle portion 1620 and the implant may be somewhat slack orat most minimally tensed. A proximal end 1652 of tubular shaft 1634 anda proximal end 1654 of inner shaft 1636 are disposed at an initialoffset distance D1 therebetween, indicative of essentially no tension incontracting member 226, i.e., that contracting member 226 is not tensed.For applications in which the implant comprises implantable annuloplastystructure 222, which comprises flexible sleeve 26, sleeve 26 (coupled toannulus 240) is in a relaxed, non-tense state. At this point, the toolhas been sufficiently advanced through vasculature of the patient suchthat the distal tip of the tool is in proximity to structure 222disposed along the annulus.

As shown, for example, in the transition between FIGS. 22A-B and FIGS.23A-B, the actuation of contraction-facilitating knob 1630 can causehandle portion 1620 to uptake successive portions of contracting member226 by:

-   -   advancing tubular shaft 1634 proximally with respect to outer        housing 1632, which advances distal force applicator 1642        proximally with respect to outer housing 1632 (distal force        applicator 1642 can be axially fixed to tubular shaft 1634        during ordinary use of handle portion 1620),    -   which applies a proximally-directed force to spring 1646,    -   which pushes inner shaft 1636 proximally with respect to outer        housing 1632 (by spring 1646 applying a proximally-directed        force to inner shaft 1636,    -   which proximally pulls contracting member 226 (which is axially        locked to inner shaft 1636 by lock 1640, as described above).

Sometimes, during the initial proximal movement of distal forceapplicator 1642 with respect to outer housing 1632 illustrated in thetransition between FIGS. 22A-B and 23A-B, contracting member 226 isrelatively slack, as mentioned above, such that inner shaft 1636 offersno or relatively little resistance to the proximally-directed forceapplied to inner shaft 1636 by spring 1646, and spring 1646 is not, oris only minimally, axially compressed. As a result, inner shaft 1636advances proximally with respect to the outer housing 1632 to the same,or approximately the same, extent as the tubular shaft 1634 advancesproximally with respect to the outer housing 1632, and the offsetdistance remains at its initial value (D1), indicating that there isstill essentially no tension in contracting member 226. This initialproximal advancement of tubular shaft 1634 and inner shaft 1636 withrespect to outer housing 1632 serves to accommodate differing initiallevels of slack in contracting member 226.

At a certain distance of proximal advancement of distal force applicator1642 with respect to outer housing 1632, contracting member 226 becomestensed (at an initial low level of tension), such that inner shaft 1636gradually offers increasing resistance to the proximally-directed forceapplied to inner shaft 1636 by spring 1646, and spring 1646 becomesgradually more compressed. As used in the present application, includingin the claims, contracting member 226 is considered to be “tensed” evenwhen tensed at a low level of tension.

As shown in the transition between FIGS. 23A-B and 24A-B, as spring 1646becomes more compressed, distal force applicator 1642 moves axiallycloser to inner shaft 1636, such that tubular shaft 1634 movesproximally with respect to inner shaft 1636. As a result, spring 1646pushes inner shaft 1636 proximally with respect to outer housing 1632 toa lesser extent than tubular shaft 1634 proximally advances with respectto outer housing 1632, and proximal pulling of the contracting member226 by the inner shaft 1636 increases tension in the contracting member226. Therefore, the offset distance between proximal end 1652 of tubularshaft 1634 and proximal end 1654 of inner shaft 1636 decreases to atensed offset distance D2, as shown in FIGS. 24A-B. (In actual use ofthe handle, many tensed offset distances D2 occur; a single offset isshown for the sake of illustration.) The tensed offset distance D2 isless than the initial offset distance D1, reflecting the fact that theportion of inner shaft 1636 that protrudes from proximal end 1652 oftubular shaft 1634 has decreased.

Contraction-facilitating knob 1630 can have any shape that enablesactuation thereof, and is not necessarily round, tubular, or generallycylindrical. For example, for some applications,contraction-facilitating knob 1630 is configured to be actuated byrotation thereof, e.g., about a central longitudinal axis of tubularshaft 1634, such as shown in the drawings. Optionally, for someapplications, contraction-facilitating knob 1630 is configured to beactuated by axially sliding thereof with respect to outer housing 1632(configuration not shown). Contraction-facilitating knob 1630 can benon-electrical, i.e., entirely mechanical, or may optionally compriseelectrical components, including, for example, circuitry.

For some applications, tubular shaft 1634 and contraction-facilitatingknob 1630 are in threaded connection with each other, and handle portion1620 is configured such that actuation of contraction-facilitating knob1630 rotates tubular shaft 1634, thereby advancing tubular shaft 1634proximally with respect to outer housing 1632. For some of theseapplications, contraction-facilitating knob 1630 is configured to beactuated by rotation thereof, e.g., about the central longitudinal axisof tubular shaft 1634, such as shown in the drawings.

For some applications, handle portion 1620 further comprises an innerstabilization tube 1680, which (a) extends proximally from and isaxially fixed to distal force applicator 1642 and (b) definestherethrough a portion of handle contracting-member-receiving channel1650. A portion of inner stabilization tube 1680 is disposed withininner-shaft contracting-member-receiving channel 1638; the length of theportion varies with the distance between distal force applicator 1642and inner shaft 1636. Spring 1646 can be configured to surround aportion of inner stabilization tube 1680 and be free to move axiallywith respect to the outer surface of inner stabilization tube 1680.

For some applications, inner shaft 1636 partially protrudes out of aproximal end 1639 of outer housing 1632, such that a portion of innershaft 1636 is visible to the user. For these applications, tubular shaft1634 and inner shaft 1636 together provide a non-electrical mechanicalforce gauge 1624, in which a relative axial position of tubular shaft1634 with respect to inner shaft 1636 (i.e., the offset distance Dbetween proximal end 1652 of tubular shaft 1634 and proximal end 1654 ofinner shaft 1636) provides a visual indication of a measure of thetension in contracting member 226. Tubular shaft 1634, at least after itbegins advancing proximally, can also protrude out of proximal end 1639of outer housing 1632. For these applications, inner shaft 1636 can bemarked with a plurality of fiduciary markers 1626, which are arrangedalong inner shaft 1636 to indicate the relative axial position of thetubular shaft 1634 with respect to the inner shaft 1636. For example,fiduciary markers 1626 may provide a reading of zero or close to zerowhen proximal end 1652 of tubular shaft 1634 and proximal end 1654 ofinner shaft 1636 are disposed as the initial offset distance D1therebetween, as shown in FIGS. 22A-B. (The force applied to spring 1646at any given level of compression of the spring equals the tension incontracting member 226.)

It is noted that force gauge 1624 does not measure the length ofcontracting member 226 that handle portion 1620 uptakes. (This uptakelength is equal to the distance that inner shaft 1636 moves proximally.)As discussed above, an initial portion of the uptake length is sometimesdue to proximal movement of inner shaft 1636 while tubular shaft 1634proximally moves approximately in tandem with inner shaft 1636 beforecontracting member 226 is tensed. During this optional initial motion,tension in contracting member 226 does not materially increase, eventhough handle portion 1620 uptakes contracting member 226.

More generally, inner shaft 1636 can be considered an axially-movableportion of force gauge 1624. The axially-movable portion of force gauge1624 is axially-movable with respect to the outer housing 1632 (and,often, with respect to one or more other portions of force gauge 1624,which themselves may or may not be axially movable with respect to outerhousing 1632).

For some applications, inner shaft 1636 does not protrude out ofproximal end 1639 of the outer housing 1632, in which case handleportion 1620 does not provide non-electrical mechanical force gauge1624. Handle portion 1620 may nevertheless still be entirely useful forregulating the tension in contracting member 226, such as isconfigurations in which handle portion 1620 further comprisestension-limiting locking assembly 1658 for limiting the maximum tensionthat inner shaft 1636 can apply to contracting member 226, as describedhereinbelow.

Reference is again made to FIGS. 24A-B and 25A-B. Reference is also madeto FIGS. 26A-B, which are schematic illustrations of a portion of outerhousing 1632 and tubular shaft 1634, in accordance with someapplications. For clarity of illustration, inner shaft 1636 is notshown. For some applications, handle portion 1620 further comprises atension-limiting locking assembly 1658, which is configured to axiallylock inner shaft 1636 with respect to outer housing 1632 when handleportion 1620 increases the tension in contracting member 226 to apredetermined threshold level, thereby limiting a maximum tension thatinner shaft 1636 can apply to contracting member 226. Tension-limitinglocking assembly 1658 can be configured to axially lock inner shaft 1636with respect to outer housing 1632 when tubular shaft 1634 is disposedat a predetermined relative axial position with respect to inner shaft1636, thereby limiting the maximum tension that inner shaft 1636 canapply to contracting member 226. Tension-limiting locking assembly 1658can also be configured to axially lock tubular shaft 1634 with respectto outer housing 1632 when tubular shaft 1634 is disposed at apredetermined relative axial position with respect to inner shaft 1636.

For some applications, tension-limiting locking assembly 1658 comprisesa detent 1660, which is arranged to axially lock inner shaft 1636 withrespect to outer housing 1632 when tubular shaft 1634 is disposed at thepredetermined relative axial position with respect to inner shaft 1636,such as shown in FIGS. 25A-B, thereby limiting the maximum tension thatinner shaft 1636 can apply to contracting member 226.

As shown in the transition between FIGS. 24A-B and 25A-B, as spring 1646becomes more compressed, distal force applicator 1642 moves axiallycloser to inner shaft 1636, such that tubular shaft 1634 movesproximally with respect to inner shaft 1636. As a result, the offsetdistance between proximal end 1652 of tubular shaft 1634 and proximalend 1654 of inner shaft 1636 decreases to a maximum-tensed offsetdistance D3 (which may optionally be zero or close to zero, asillustrated), which is less than the tensed offset distance D2, andequal to the above-mentioned predetermined relative axial position oftubular shaft 1634 with respect to inner shaft 1636. Often, but notnecessarily, a relatively small portion of inner shaft 1636 stillprotrudes from proximal end 1652 of tubular shaft 1634, particularly inconfigurations in which handle portion 1620 provides non-electricalmechanical force gauge 1624, as described above.

For applications in which the implant comprises implantable annuloplastystructure 222, which comprises flexible sleeve 26, sleeve 26 ofannuloplasty structure 222 coupled to annulus 240 can be in a tense,contracted state.

Tension-limiting locking assembly 1658 optionally obviates the need fornon-electrical mechanical force gauge 1624, described hereinabove. Inaddition, for applications in which force gauge 1624 is provided,tension-limiting locking assembly 1658 obviates the need for the user torepeatedly check the reading of force gauge 1624, thereby allowing theuser to focus attention on other aspects of the procedure, such asfluoroscopy images. Often, the predetermined relative axial position oftubular shaft 1634 with respect to inner shaft 1636 has the effect ofsetting a predetermined maximum tension that can be applied tocontracting member 226 using contracting-member-uptake tool 1600.

It is noted that tension-limiting locking assembly 1658 often does notaxially lock inner shaft 1636 directly in response to the length ofcontracting member 226 that handle portion 1620 uptakes. (This uptakelength is equal to the distance that inner shaft 1636 moves proximally.)In addition, tension-limiting locking assembly 1658 often does notaxially lock inner shaft 1636 directly in response to relative axialmovement between inner shaft 1636 and outer housing 1632, or directly inresponse to relative axial movement between tubular shaft 1634 and outerhousing 1632. As discussed above, an initial portion of the uptakelength is sometimes due to proximal movement of inner shaft 1636 whiletubular shaft 1634 proximally moves approximately in tandem with innershaft 1636 before contracting member 226 is tensed. Sincetension-limiting locking assembly 1658 is often configured to axiallylock inner shaft 1636 with respect to outer housing 1632 when tubularshaft 1634 is disposed at a predetermined relative axial position withrespect to inner shaft 1636, tension-limiting locking assembly 1658 isnot affected or triggered by any movement of inner shaft 1636 andtubular shaft 1634 in tandem with each other.

For some applications, detent 1660 is coupled in axial fixation withinner shaft 1636, and is configured to move radially outward so as toengage outer housing 1632 in order to axially lock inner shaft 1636 withrespect to outer housing 1632, such as shown in FIGS. 24A-B. Forexample, a detent-spring 1684 can be provided that applies aradially-outwardly-directed force to detent 1660. Handle portion 1620 isconfigured such that when tubular shaft 1634 is not disposed at thepredetermined relative axial position with respect to inner shaft 1636,such as shown in FIGS. 22A-23B, an element of handle portion 1620prevents the radially-outward motion of detent 1660, for example asdescribed below. As used in the present application, including in theclaims, “radially outward” means in a direction farther from a centrallongitudinal axis of outer housing 1632, and “radially inward” means inthe opposite direction closer to the central longitudinal axis.

For some applications, tension-limiting locking assembly 1658 furthercomprises a plurality of indentations 1662 that outer housing 1632 isshaped so as to define. Detent 1660 is engageable with indentations 1662to axially lock inner shaft 1636 with respect to outer housing 1632.Handle portion 1620 is arranged such that the particular one ofindentations 1662 with which detent 1660 engages depends upon a relativeaxial position of inner shaft 1636 with respect to outer housing 1632when tubular shaft 1634 is disposed at the predetermined relative axialposition with respect to inner shaft 1636. In this arrangement, eventhough the relative axial position of tubular shaft 1634 with respect toinner shaft 1636 at which detent 1660 axially locks inner shaft 1636with respect to outer housing 1632 is predetermined, the relativepositions of tubular shaft 1634 and inner shaft 1636 with respect outerhousing 1632 can vary to accommodate differing initial levels of slackin contracting member 226.

For some applications, wherein proximal longitudinal portion 1637 oftubular shaft 1634 is shaped so as to define an elongate opening 1664through which detent 1660 passes when detent 1660 axially locks innershaft 1636 with respect to outer housing 1632. For some of theseapplications, tubular shaft 1634 comprises one or more tracks 1666 thatrun alongside a longitudinal portion of elongate opening 1664 and arearranged to:

-   -   prevent detent 1660 from axially locking inner shaft 1636 with        respect to outer housing 1632 when tubular shaft 1634 is        disposed distally to the predetermined relative axial position        with respect to inner shaft 1636 (by blocking the        radially-outward motion of detent 1660), and        -   allow detent 1660 to axially lock inner shaft 1636 when            tubular shaft 1634 is disposed at the predetermined relative            axial position with respect to inner shaft 1636 (by allowing            the radially-outward motion of detent 1660).

A portion of the one or more tracks 1666 that prevents detent 1660 fromaxially locking inner shaft 1636 with respect to outer housing 1632 canbe disposed radially inward of a portion of the one or more tracks 1666that allows detent 1660 to axially lock inner shaft 1636.

For some of these applications, proximal longitudinal portion 1637 oftubular shaft 1634 comprises one or more detent supports 1688, which arefixed to detent 1660 and are configured to axially slide along the oneor more tracks 1666. When tubular shaft 1634 is disposed distally to thepredetermined relative axial position, the one or more tracks 1666prevent radially-outward motion of the one or more detent supports 1688,thereby preventing the radially-outward motion of detent 1660. For someapplications, proximal longitudinal portion 1637 of tubular shaft 1634comprises one or more detent support posts 1690, which stabilize the oneor more detent supports 1688 during radial motion thereof; the one ormore detent supports 1688 can slide radially with respect to the one ormore detent support posts 1690.

For some of these applications, the one or more tracks 1666 are shapedso as to define one or more respective sloping portions 1668. Afterdetent 1660 axially locks inner shaft 1636 with respect to outer housing1632 when tubular shaft 1634 is disposed at the predetermined relativeaxial position with respect to inner shaft 1636, subsequentdistally-directed motion of tubular shaft 1634 and correspondingdistally-directed motion of the one or more tracks 1666 with respect toinner shaft 1636 disengages detent 1660 from outer housing 1632. Forexample, this disengagement can be caused by the one or more slopingportions 1668 sliding the one or more detent supports 1688 radiallyinward and onto the portion of the one or more tracks 1665 that aredisposed radially inward. The distally-directed motion of tubular shaft1634 can be caused by actuation of contraction-facilitating knob 1630 inthe opposite direction of actuation for the proximally-directed motiondescribed hereinabove. This allows the user to reduce the tension incontracting member 226 if necessary during the procedure, even if thelevel of tension was high enough to trigger the tension-limiting lockingof detent 1660. Of course, if necessary the user can also reduce thetension in contracting member 226 even before the tension-limitinglocking of detent 1660.

For some applications, once the desired level of tension in contractingmember 226 is achieved (by monitoring force gauge 1624, by detent 1660limiting the maximum tension, and/or, for example, by monitoring theextent of regurgitation of the valve under echocardiographic and/orfluoroscopic guidance), contracting-member-uptake tool 1600 lockscontracting member 226 so as to maintain a degree of tension incontracting member 226 in order to maintain contracting member 226 (and,optionally, structure 222, if provided) in a contracted state.

For some applications, as perhaps can best be seen in the blow-up inFIG. 25B, detent 1660 and/or indentations 1662 are slightly angled(e.g., between 1 and 45 degrees, such as between 1 and 30 degrees, e.g.,between 1 and 15 degrees, such as about 5 degrees) with respect to adirection perpendicular to the central longitudinal axis of handleportion 1620, such that detent 1660 faces slightly in a proximaldirection and/or the openings of indentations 1662 face slightly in adistal direction. Because detent 1660 moves proximally immediatelybefore engaging one of indentations 1662, this angling eases thecatching and engagement of the detent with indentation 1662, and canalso ease disengagement if necessary, as discussed above. Alternatively,detent 1660 and/or indentations 1662 are not angled and areperpendicular to the central longitudinal axis of handle portion 1620.

Reference is again made to FIGS. 21A-B. For some applications, spring1646 is preloaded when proximal end 1652 of tubular shaft 1634 andproximal end 1654 of inner shaft 1636 are disposed at the initial offsetdistance D1 therebetween. Often, handle portion 1620 is configured tomaintain this preload before use of handle portion 1620, by preventingproximal advancement of inner shaft 1636 with respect to tubular shaft1634 beyond a predetermined maximum distance. For example, a proximalend of elongate opening 1664 (shown, for example, in FIG. 22B) may blockproximal advancement of an element of tension-limiting locking assembly1658 (e.g., one or more of the detent support posts 1690 or a proximalportion of the one or more detent supports 1688, labeled in FIG. 26A).Setting of the preload is described immediately hereinbelow.

Reference is again made to FIG. 21B. For some applications, aradially-inward surface of tubular shaft 1634 near a distal end thereofis shaped so as to define a thread 1682, and a radially-outward surfaceof distal force applicator 1642 is shaped so as to define acorresponding thread 1686. The threads allow the adjustment of theprecise axial location of distal force applicator 1642 with respect totubular shaft 1634 during a calibration procedure during manufacture ofhandle portion 1620, by rotation of distal force applicator 1642 withrespect to tubular shaft 1634. For example, this rotation can be readilyperformed before insertion into outer housing 1632 of tubular shaft1634, inner shaft 1636, distal force applicator 1642, spring 1646, andthe other elements fixed to inner shaft 1636. During use of handleportion 1620 during a medical procedure, as described hereinabove,distal force applicator 1642 is rotationally fixed, and thus axiallyfixed, with respect to tubular shaft 1634.

For some applications, the adjustment of the axial location of distalforce applicator 1642 with respect to tubular shaft 1634 during thecalibration procedure adjusts the preload in spring 1646 (by compressionof the spring) to set a desired level of maximum tension that innershaft 1636 can apply to contracting member 226. For example, adistally-directed force can be applied to proximal end 1654 of innershaft 1636 until the offset distance between proximal end 1652 oftubular shaft 1634 and proximal end 1654 of inner shaft 1636 decreasesto the maximum-tensed offset distance D3 (at which tension-limitinglocking assembly 1658 is triggered during subsequent use). This applieddistally-directed force can be measured with a force gauge, and theaxial location of distal force applicator 1642 with respect to tubularshaft 1634 may be adjusted until the applied distally-directed forceequals the desired level of maximum tension that inner shaft 1636 canapply to contracting member 226 before tension-limiting locking assembly1658 is triggered during subsequent use. Upon removal of thiscalibration distally-directed force, spring 1646 will elongate untilfurther advancement of inner shaft 1636 is blocked, as described above,and spring 1646 will have a desired level of preload.

Reference is again made to FIGS. 1-26B. Systems 10, 510, 700, 800, 900,1000, 1100, 1200, 1300, 1350, 1400, 1480, and 1500 and methods forrepairing a dilated annulus of the patient can be used to treat anycardiac valve of the patient, e.g., the aortic valve, the pulmonaryvalve, the mitral valve, and the tricuspid valve. Further, systemsdescribed herein for treatment of valves can be used to treat otherannular muscles within the body of the patient. For example, the systemsdescribed herein can be used in order to treat a sphincter muscle withina stomach of the patient.

Reference is again made to FIGS. 1-26B. Systems 10, 510, 700, 800, 900,1000, 1100, 1200, 1300, 1350, 1400, 1480, and 1500 can be anchored totissue of the annulus using any of the anchoring devices described in USPatent Application Publication 2015/0272734 to Sheps et al., includingthe anchor driver and the deployment manipulator.

Reference is again made to FIGS. 1-26B. Systems 10, 510, 700, 800, 900,1000, 1100, 1200, 1300, 1350, 1400, 1480, and 1500 and methods describedhereinabove can be used on any suitable tissue of the patient (e.g.,stomach tissue, urinary tract, and prostate tissue).

Reference is now made to FIGS. 1-26B. Tools described herein can be usedto deploy, anchor, and adjust a perimeter of any annuloplasty structure,e.g., a full (or closed) annuloplasty structure or a partial (or open)annuloplasty structure. Any tool described herein can be coupled to theannuloplasty structure using any coupling described herein withreference to FIGS. 7A-26B. For example, any annuloplasty structuredescribed herein can comprise housing 930 having female coupling 927 andthe tools described herein can comprise male coupling 925 tools asdescribed hereinabove with reference to FIGS. 12, 13, and 15. Theannuloplasty structures described herein can comprise elements andstructures as described in PCT Publication WO 10/073246 to Cabiri et al.which is incorporated herein by reference.

Additionally, applications described in one or more of the following canbe used with the various embodiments in this disclosure:

-   -   U.S. patent application Ser. No. 12/435,291 to Maisano et al.,        entitled, “Adjustable repair chords and spool mechanism        therefor,” filed on May 4, 2009, which issued as U.S. Pat. No.        8,147,542;    -   U.S. patent application Ser. No. 12/437,103 to Zipory et al.,        entitled, “Annuloplasty ring with intra-ring anchoring,” filed        on May 7, 2009, which issued as U.S. Pat. No. 8,715,342;        -   U.S. patent application Ser. No. 12/548,991 to Maisano et            al., entitled, “Implantation of repair chords in the heart,”            filed on Aug. 27, 2009, which issued as U.S. Pat. No.            8,808,368;        -   PCT Patent Application PCT/IL2009/001209 to Cabiri et al.,            entitled, “Adjustable annuloplasty devices and mechanisms            therefor,” filed on Dec. 22, 2009, which published as PCT            Publication WO 10/073246;    -   PCT Patent Application PCT/IL2010/000357 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed on        May 4, 2010, which published as WO 10/128502;        -   PCT Patent Application PCT/IL2010/000358 to Zipory et al.,            entitled, “Deployment techniques for annuloplasty ring and            over-wire rotation tool,” filed on May 4, 2010, which            published as WO 10/128503;    -   US Patent Application Publication 2014/0309661 to Sheps et al.;        and/or        -   US Patent Application Publication 2015/0272734 to Sheps et            al.

All of these applications are incorporated herein by reference.Techniques described herein can be practiced in combination withtechniques described in one or more of these applications. Additionally,any and all of the methods, techniques, steps, etc. described herein canbe performed on a living animal or in a simulation/simulated method(e.g., on a cadaver, cadaver heart, simulator with a simulated heart,tissue, etc., anthropomorphic ghost, etc.)

The present invention is not limited to what has been particularly shownand described hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

The invention claimed is:
 1. Apparatus, comprising: an implantableannuloplasty structure comprising: a primary body portion; and acontracting member having (1) a first portion extending along alongitudinal length of the primary body portion of the annuloplastystructure, and (2) a second portion extending away from the primaryportion of the annuloplasty structure; at least one fastener configuredto surround the contracting member, the fastener comprising a clampingstructure that: (a) is biased toward assuming a closed state, in theclosed state, the clamping structure is configured to clamp onto thecontracting member passed therethrough, and (b) can be flexed to an openstate through which the contracting member can move; a stop removablycoupled to the fastener and configured to maintain the fastener in theopen state; and a severing tool comprising: a static cutting elementhaving a first cutting surface; and a dynamic cutting element having asecond cutting surface that opposes the first cutting surface; and oneor more graspers configured to pull the stop proximally and remove thestop from the fastener, wherein: a portion of the contracting memberpasses through the static cutting element and through the dynamiccutting element, and once pulled proximally, the stop contacts thecutting element and is configured to push against and move the dynamiccutting element with respect to the static cutting element in order tofacilitate severing of the contracting member.
 2. The apparatusaccording to claim 1, wherein the first and second cutting surfaces areeach concave.
 3. The apparatus according to claim 1, wherein the firstand second cutting surfaces are each diagonal.
 4. The apparatusaccording to claim 1, wherein the severing tool is arranged such thatthe severing tool provides a safety mechanism whereby movement of thedynamic cutting element with respect to the static cutting element ispossible only with pushing of the stop against the dynamic cuttingelement.
 5. The apparatus according to claim 1, further comprising ahousing that houses the fastener and the stop, and wherein the severingtool is coupled to the housing as the graspers grasp the stop.
 6. Theapparatus according to claim 5, wherein the severing tool is configuredto deliver the housing, the fastener, and the stop to the implantableannuloplasty structure.
 7. The apparatus according to claim 5, whereinthe implantable annuloplasty structure comprises the housing.
 8. Theapparatus according to claim 1, wherein the stop is shaped so as todefine an overhang, and wherein the graspers are configured to grip theoverhang in order to initially couple the severing tool to the fastener.9. The apparatus according to claim 8, further comprising an outersleeve portion configured to surround the graspers in order to lock thegraspers with respect to the overhang.
 10. Apparatus for use with awire, the apparatus comprising: a fastener configured to receive thewire therethrough such that the fastener surrounds the wire, thefastener comprising a clamping structure that: (a) is biased towardassuming a closed state, in the closed state, the clamping structure isconfigured to clamp onto the wire passed therethrough, and (b) can beflexed to an open state through which the wire can move; a stopremovably coupled to the fastener and configured to maintain thefastener in the open state; and a severing tool comprising: a cuttingelement configured to cut the wire; and one or more graspers configuredto engage the stop and to pull the stop proximally and remove the stopfrom the fastener such that: the fastener transitions toward the closedstate, and the stop pushes against and moves the cutting element in amanner that severs the wire.
 11. The apparatus according to claim 10,wherein the severing tool is arranged such that the severing toolprovides a safety mechanism whereby movement of the cutting element ispossible only with pushing of the stop against the cutting element. 12.The apparatus according to claim 10, further comprising a housing thathouses the fastener and the stop, and wherein the severing tool iscoupled to the housing as the graspers grasp the stop.
 13. The apparatusaccording to claim 12, further comprising an implantable annuloplastystructure, wherein the severing tool is configured to deliver thehousing, the fastener, and the stop to the implantable annuloplastystructure.
 14. The apparatus according to claim 12, further comprisingan implantable annuloplasty structure, wherein the implantableannuloplasty structure comprises the housing.
 15. The apparatusaccording to claim 10, wherein the stop is shaped so as to define anoverhang, and wherein the graspers are configured to grip the overhangin order to initially couple the severing tool to the fastener.
 16. Theapparatus according to claim 15, further comprising an outer sleeveportion configured to surround the graspers in order to lock thegraspers with respect to the overhang.
 17. A system, comprising: animplant comprising a contracting member; at least onecontracting-member-fastener configured to surround the contractingmember, the contracting-member-fastener comprising a clamping structurethat (a) is biased toward assuming a closed state, in the closed state,the clamping structure is configured to clamp onto the contractingmember passed therethrough, and (b) can be flexed to an open statethrough which the contracting member can move; a stop removably coupledto the contracting-member-fastener and configured to maintain thecontracting-member-fastener in the open state; and a severing toolcomprising a cutting element configured to cut the contracting member;wherein when pulled proximally, the stop contacts the cutting elementand is configured to push against and move the cutting element in orderto facilitate severing of the contracting member by the cutting element.18. The system according to claim 17, wherein the severing tool isarranged such that the severing tool provides a safety mechanism wherebymovement of the cutting element is possible only with pushing of thestop against the cutting element.
 19. The system according to claim 17,further comprising a housing that houses the fastener and the stop, andwherein the severing tool is coupleable to the housing.
 20. The systemaccording to claim 19, wherein the implant is an implantableannuloplasty structure, and wherein the severing tool is configured todeliver the housing, the fastener, and the stop to the implantableannuloplasty structure.